List of Abbreviations
BP — blood pressure
WHO - World Health Organization
GIT - gastrointestinal tract
ELISA - enzyme-linked immunosorbent assay
Russian Ministry of Health - Ministry of Health of the Russian Federation
ICD-10 - International Statistical Classification of Diseases and Related Health Problems 10th Revision
AII - acute intestinal infections
PRV - pentavalent rotavirus vaccine
PCR — polymerase chain reaction
RVG - rotavirus gastroenteritis
RVI - rotavirus infection
IFA - immunofluorescence assay
RNA - ribonucleic acid
ESR – erythrocyte sedimentation rate
FZ - federal law
CNS - central nervous system
RR - respiratory rate
HR – heart rate
SD - sparing diet (mechanically and chemically sparing)
ECG - electrocardiography
Ig M, G - immunoglobulins class M, G
pH - hydrogen ion exponent
g - gram
mg - milligram
min. - minute
mL - milliliter
mmHg - millimeters of mercury
nm – nanometer – 10⁻⁹ meters
Terms and Definitions
Clinical guidelines (treatment protocol) are a normative document of the healthcare standardization system that defines the requirements for providing medical care to a patient with a specific disease, syndrome, or clinical situation.
Nosological form is a set of clinical, laboratory, and instrumental diagnostic signs that allow the identification of a disease (poisoning, injury, physiological state) and classify it into a group of conditions with a common etiology and pathogenesis, clinical manifestations, and general approaches to treatment and condition correction.
Disease is an event arising from the impact of pathogenic factors that impair the body's activity, working capacity, and ability to adapt to changing environmental and internal conditions, while simultaneously altering the body's protective-compensatory and protective-adaptive reactions and mechanisms.
Primary disease is a disease that, by itself or through its complications, creates the primary need for medical care due to the greatest threat to working capacity, life, and health, or leads to disability, or causes death.
Concomitant disease is a disease that has no causal relationship with the primary disease, is inferior to it in terms of the need for medical care, impact on working capacity, risk to life and health, and is not the cause of death.
Severity of a disease or condition is a criterion that determines the degree of damage to human organs and/or body systems or the impairment of their functions caused by the disease, condition, or their complications.
Disease outcomes are the medical and biological consequences of a disease.
Consequences (results) are disease outcomes, as well as the social and economic results of applying medical technologies.
Disease complication is the addition to a disease of a syndrome of physiological process disruption: violation of the integrity of an organ or its wall; hemorrhage; developing acute or chronic failure of an organ function or organ system.
Condition is changes in the body arising from the impact of pathogenic and/or physiological factors that require medical care.
Clinical situation is a case requiring the regulation of medical care regardless of the disease or syndrome.
Syndrome is a condition developing as a consequence of a disease and defined by a set of clinical, laboratory, and instrumental diagnostic signs that allow its identification and classification into a group of conditions with different etiologies but common pathogenesis, clinical manifestations, and general treatment approaches, which nevertheless depend on the underlying diseases.
Symptom is any sign of a disease that can be determined regardless of the method used for this purpose.
Patient is an individual who is receiving medical care or who has applied for medical care regardless of whether they have a disease and regardless of their condition.
Medical intervention is a set of medical examinations and/or medical manipulations, as well as artificial termination of pregnancy, performed by a medical worker in relation to a patient, affecting the physical or mental state of a person, and having a preventive, exploratory, diagnostic, therapeutic, or rehabilitative orientation.
Medical service is a medical intervention or a complex of medical interventions aimed at the prevention, diagnosis, and treatment of diseases, and medical rehabilitation, having an independent completed significance.
Quality of medical care is a set of characteristics reflecting the timeliness of medical care, the correctness of the choice of prevention, diagnosis, treatment, and rehabilitation methods during the provision of care, and the degree to which the planned result is achieved.
Physiological process is an interrelated aggregate activity of various cells, tissues, organs, or organ systems (an aggregate of functions) aimed at satisfying the vital needs of the entire organism.
Function of an organ, tissue, cell, or group of cells is a property constituting a physiological process that realizes an action specific to the corresponding structural unit of the organism.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Rotavirus gastroenteritis is an acute anthroponotic infectious disease with a fecal-oral transmission mechanism, caused by rotaviruses, and characterized by damage to the gastrointestinal tract of the gastroenteritis type with the development of dehydration syndrome [1,2].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Etiology. The causative agent of the disease is the rotavirus. Rotaviruses belong to the genus Rotavirus of the family Reoviridae. The rotavirus virion consists of a core containing a genome represented by double-stranded RNA consisting of 11 segments, surrounded by two layers of protein coats with a diameter of 70–75 nm. Since the virus has a ring structure resembling spokes and a rim, it was named "rotavirus" from the Latin word "rota" (wheel). The outer coat is formed by structural proteins VP4 and VP7, which determine the P1-P8 and G1-G14 serotypes of rotaviruses, respectively [1,3,4].
The inner capsid of the virus contains the structural protein VP6, which determines the serogroup. Based on the structure of the group antigen, rotaviruses are divided into 7 serogroups (A-G). This group antigen is detected by immunological methods (ELISA, immunofluorescence, etc.).
Structural proteins determine the processes of virus adsorption and its penetration into epithelial cells, participate in the subsequent transcription of viral RNA, and initiate an immune response. Rotaviruses contain both structural and non-structural proteins. The non-structural NSP4 peptide has enterotoxin properties and takes direct part in the development of secretory-type diarrhea [2].
Pathogenesis. Rotaviruses cause direct damage to the intestinal epithelium. Due to their resistance to proteolytic enzymes and bile, the viruses reach the epithelium of the small intestine and invade highly differentiated villous cells. Penetration inside the cell causes damage to the cytoskeleton of epithelial cells and their detachment, followed by replacement with immature cells. Damage to up to 2/3 of the small intestinal mucosa is possible. As a result, the enzymatic systems of enterocytes that break down carbohydrates—primarily lactose—are disrupted, leading to the development of secondary lactase deficiency.
The accumulation of an excessive amount of non-hydrolyzed carbohydrates is accompanied by an increase in osmotic pressure in the large intestine, impaired reabsorption of water and electrolytes. During the fermentation of uncleaved disaccharides by the intestinal microflora, a large amount of organic acids, hydrogen, carbon dioxide, and water is formed, which leads to increased gas production in the intestine and a decrease in the pH of the intestinal contents. Watery (osmotic) diarrhea occurs due to enzymatic dysfunction.
In addition, the non-structural protein NSP4, which is a virus-specific enterotoxin, plays a role in the mechanism of diarrhea development in RVI. Inflammatory changes in the intestinal mucosa do not play a role in the development of diarrhea in RVI, as it occurs even at a low viral load prior to the development of cytopathological changes. It has also been noted that cAMP and cGMP levels in epithelial cells do not change, while alkaline phosphatase indicators decrease.
Along with enzymopathy in the pathogenesis of RVI, as in other acute intestinal infections, the developing imbalance of the intestinal microbiocenosis is of great importance. The imperfection of the enzymatic and barrier systems of the gastrointestinal tract in childhood contributes to the disruption of the metabolism of normal microflora, which is accompanied by the colonization of the intestinal mucosa by opportunistic microorganisms.
The development of rotavirus gastroenteritis depends on a number of causes: the pH state of gastric juice (an acidic environment is detrimental to the rotavirus), the presence of a trypsin inhibitor (trypsin is an activator of virus reproduction), and the number of functionally immature enterocytes.
There is evidence of the role of viremia in the development of extraintestinal foci in RVI with virus replication in various organs and systems (liver, kidneys, kidneys, heart, brain). In immunocompromised children, rotaviruses can cause the development of hepatitis, nephritis, pneumonia, exanthema, DIC syndrome, encephalopathy, and encephalitis with a high risk of fatal outcomes. The etiopathogenetic connection of disaccharidase deficiency syndrome with chronic persistent RVI has also been established. An association between chronic gastroenterological pathology and the persistence of rotaviruses has been suggested.
It has been established that the immune response in rotavirus infection is multidirectional, being formed through the combined action of secretory antibodies, humoral, and cell-mediated immune responses.
It has been proven that humoral immunity plays a key role in protection against subsequent rotavirus infections, while the cell-mediated response reduces the duration of clinical manifestations of the infection. Group and type heterogeneity of rotaviruses leads to recurrent episodes of this infection. The probability of reinfection in the first year of life is 30%, and by the age of two, practically 70% of children have contracted rotavirus infection twice.
Post-infection immunity in rotavirus infection is serospecific, with maximum protection achieved only after 3 consecutive episodes of the disease contracted at short intervals, since in such cases, in 91% of patients, they are caused by different rotavirus serotypes [2].
The stages of pathogenesis and their characteristics are presented in Table 1.
Table 1. Stages of pathogenesis and their characteristics
Stages of pathogenesis | Characteristic |
|---|---|
Infection | Human infection occurs when rotaviruses enter the gastrointestinal tract. This results in either rotavirus carriage or the development of a manifest form of the disease. |
Intoxication syndrome | Viremia and resorption of toxic substances lead to the development of intoxication syndrome (weakness, headache, sleep disorders). |
Diarrhea syndrome | Intestinal involvement in patients manifests as copious watery stools. The frequency of bowel movements can reach 20 or more times per day, leading to dehydration and weight loss. |
Abdominal pain syndrome | Pronounced meteorism and overdistension of intestinal loops by liquid contents are accompanied by pain in the upper and lower abdomen, abdominal tenderness upon palpation, and frequent passage of gas. |
Extraintestinal manifestations of rotavirus infection | The pathogenesis of extraintestinal manifestations has not been fully studied. |
Complications of rotavirus gastroenteritis | Dehydration syndrome, febrile and afebrile seizures, intussusception. |
1.3 Epidemiology of the Disease or Condition
Rotavirus infection is widespread worldwide. The source of infection is exclusively humans (patients with manifest forms or virus excretors); feces contain huge amounts of viruses (up to $10^{10}-10^{11}$ viral particles per 1 g). Mammalian and avian rotaviruses are non-pathogenic to humans under natural conditions. The fecal-oral transmission mechanism is most commonly realized through water and contact-household routes, and less frequently through food (milk, dairy products, infant formula); the possibility of aerosol transmission (primarily with vomitus) is debated. The infectious dose is low, 100-1000 viral particles [4-6].
Rotaviruses of serogroups A, B, and C play a role in human pathology, with the majority of cases caused by serogroup A (up to 70%). Only 5 genotypes of group A—G1P[8], G2P[4], G3P[8], G4P[8], and G9P[8]—are widespread globally (95%). The predominant genotypes can vary significantly depending not only on the continent and specific region, but also on the season, even within the same geographical areas. The rotavirus type generally does not correlate with disease severity. Certain rotavirus serotypes are known to cause infection exclusively in newborns: G3P[8], G9P[8], G10P[8]. Rotaviruses of serogroup B more frequently cause infection in adults and older children [1, 4, 5].
The virus is highly stable in the external environment; upon freezing, it remains viable for several months, while boiling rapidly destroys it. Rotaviruses are a major cause of acute intestinal infections accompanied by dehydration syndrome in children (up to 60-75% of all diarrheas) in countries where rotavirus vaccination is not implemented [4, 6].
Rotavirus infection can occur as sporadic cases, group illnesses, and mass outbreaks. Nosocomial infection via the contact-household route is possible in hospitals, with medical staff frequently serving as the source of infection. Rotavirus gastroenteritis affects individuals of all ages, but peak incidence is observed in children in the first two years of life (with a peak between 6 and 18 months), elderly individuals, and immunocompromised persons.
In temperate climates, there is a clear seasonality of rotavirus infection with a peak during the winter-spring period [2-6].
1.4 Features of Coding the Disease or Condition
A08.0 Rotavirus gastroenteritis
1.5 Classification of the disease or condition
Clinical classification of rotavirus infection
By type: typical (manifest form); atypical (latent form, or carrier state)
By form: monoinfection; combined form (with other infectious diseases)
By severity: mild; moderate; severe
By presence of complications: uncomplicated; complicated (dehydration syndrome, hypovolemic shock, acute renal failure; intussusception, hepatitis, pancreatitis, cardiomyopathy, central nervous system lesions, toxic-dystrophic syndrome)
By clinical course: acute (up to 14 days); chronic [1].
1.6 Clinical presentation of the disease or condition
The incubation period for rotavirus infection ranges from 12 hours to 3-5 days (most commonly 1-2 days). The main symptoms of rotavirus gastroenteritis are general intoxication (fever, lethargy, vomiting, headache) and gastrointestinal disturbances: abdominal pain, frequent watery stools [1, 7, 8].
Rotavirus gastroenteritis is characterized by two variants of onset: acute (about 90% of patients), when all main symptoms appear on the 1st day of illness, and subacute, when diarrhea, vomiting, and fever join the initial 1-2 symptoms (usually abdominal pain and intoxication) by the 2nd-3rd day of illness.
The majority of rotavirus infection cases begin acutely with a temperature rise to febrile levels or even hyperthermia; however, the duration of fever, despite its intensity, rarely exceeds 2-4 days. Fever is accompanied by intoxication symptoms: weakness, lethargy, decreased appetite up to the development of anorexia and adynamia in severe forms of the disease. In older children with mild forms, the disease may occur against the background of subfebrile or normal temperature with mildly expressed intoxication symptoms or their absence.
One of the first, and frequently leading, manifestations of rotavirus infection is vomiting. It may occur simultaneously with diarrhea or precede it, and can be repetitive or multiple over the course of 1-2 days.
Gastrointestinal tract involvement proceeds as gastroenteritis or (less frequently) enteritis. Diarrheal syndrome in rotavirus infection is one of the most important and constant manifestations, in some cases determining the clinical picture of the disease. Stools are copious, watery, foamy, yellow, without visible pathological admixtures or with a small amount of clear mucus; a characteristic sour odor of feces is sometimes noted. Stool frequency on average does not exceed 4-7 times per day, but can reach 15-25 times [7, 8].
The duration of diarrhea averages from 3 to 7 days, but may persist for a longer time (up to 10-14 days, more commonly in young children). Rotavirus infection is characterized by a combination of diarrhea with meteorism, which is most pronounced in infants.
Abdominal pain syndrome in rotavirus infection appears at the onset of the disease. Abdominal pains of varying severity may be generalized or localized in the upper abdomen; episodes of cramping pain may also occur.
The severity of rotavirus gastroenteritis is determined by the volume of pathological fluid losses via vomiting and diarrhea and the development of grade I-II, less frequently grade III-III [sic: II-III] exicosis. The degree of exicosis in patients depends not only on the severity of pathological fluid and electrolyte losses, but also on the adequacy of ongoing rehydration therapy [9-11].
In 60-70% of patients with rotavirus infection, minimal upper respiratory catarrhal phenomena occur, which may precede intestinal dysfunction. Respiratory syndrome is characterized by moderate hyperemia and granularity of the posterior pharyngeal wall, soft palate, and palatine arches, nasal congestion, and coughing. However, the presence of catarrhal phenomena in some cases may be due to a concomitant respiratory viral infection, especially during the period of its seasonal incidence peak [7, 8].
During the acute period of rotavirus infection against the background of febrile temperature, convulsive syndrome may develop. Seizures are mostly tonic-clonic, generalized, accompanied by loss of consciousness, and caused by the development of an encephalitic reaction. An important role in the genesis of convulsive syndrome belongs to metabolic and electrolyte disorders developing during severe dehydration [7, 8].
2. Diagnostics, medical indications and contraindications for diagnostic methods
Diagnosis of rotavirus gastroenteritis requires analysis of complaints, epidemiological history, physical examination data, and laboratory and instrumental studies [9, 12].
2.1 Complaints and Anamnesis
• It is recommended for all patients to take an anamnesis and record complaints; evaluate epidemiological history data (winter-spring period, absence of vaccination against rotavirus infection, early age, attending a preschool educational institution, contact with sick children in the family or elsewhere) [9, 12]
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Infection can occur through contact with rotavirus infection patients or rotavirus carriers, as well as by consuming water contaminated with rotaviruses. Foodborne outbreaks of infection are rare.
• It is recommended that all patients be evaluated for complaints of watery stool, possibly combined with vomiting, taking into account their duration and severity [9,10,12].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Watery stool combined with abdominal pain and flatulence is characteristic.
• It is recommended that all patients be questioned regarding decreased diuresis (frequency and volume of urination) and the presence of thirst [1,9,10,12].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Rotavirus infection is characterized by the development of dehydration syndrome.
• It is recommended that all patients be assessed for signs of intoxication (headaches, decreased appetite, impaired general well-being) [7, 8, 13].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Mild to moderate headaches, decreased appetite, lethargy, and nausea indicate the development of intoxication in patients with rotavirus infection.
2.2 Physical Examination
Physical examination findings are described in the section "Clinical Presentation".
• It is recommended that all patients have their body temperature measured in the morning and evening [7, 8, 14].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: An increase in body temperature above 40°C in rotavirus infection and/or persistence of fever for more than 3 days indicates the possible development of complications.
• It is recommended that all patients undergo measurement of heart rate, respiratory rate, and blood pressure [9,10, 14].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Changes in heart rate, respiratory rate, and blood pressure may indicate the development of complications.
• It is recommended that all patients undergo body weight measurement [9-11]
Comments: weight loss may occur with the development of dehydration syndrome.
LOE CLOE 5Level of recommendation strength C (level of evidence - 5).
• It is recommended to assess the degree of dehydration, including the use of the CDS scale to assess the severity of dehydration (Appendix G1) [9-11, 15].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5). Comments: Rotavirus infection is characterized by the rapid development of varying degrees of dehydration.
2.3 Laboratory Diagnostics
At the diagnostic stage:
• It is recommended that all patients undergo a coprological examination [1, 16, 17].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5). Comments: Coprograms may reveal acidic pH, signs of enzymatic disorders, and transparent mucus.
• It is recommended that all patients undergo etiological diagnostics: detection of rotavirus antigens (Rotavirus gr. A) in stool samples, molecular biological examination of stool for rotaviruses (Rotavirus gr. A), determination of rotavirus RNA (Rotavirus gr. A) in stool samples by PCR, rapid immunochromatographic stool test for rotavirus [9-11].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: This test is informative for the etiological diagnosis of the disease. However, it is known that the etiology of acute gastroenteritis does not affect the tactics of pathogenetic therapy.
• It is recommended that all patients undergo molecular genetic, immunochromatographic, or microbiological (culture) examination of feces/rectal swab to detect nucleic acids, bacterial antigens, or microorganism colonies to exclude a bacterial etiology of diarrhea [1, 9, 10, 11].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: This test is informative for identifying the etiological nature of the disease. However, it is known that the etiology of acute gastroenteritis does not affect the tactics of pathogenetic therapy [10].
• It is recommended in cases of grade I–II and II–III dehydration to determine blood electrolytes: sodium, potassium, and chloride levels [10, 11].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: This test is informative for diagnosing electrolyte disorders in rotavirus infection.
• It is recommended to perform a complete (clinical) blood count, differential white blood cell count, and hematocrit in patients with moderate and severe rotavirus infection [1, 9, 11].
Strong Recommendation Level CEvidence Level 5Level of recommendation confidence C (evidence reliability level - 5).
Comments: This test is informative for diagnosing a complicated course of rotavirus infection; however, the detection of leukocytosis and neutrophilia in the clinical blood count does not indicate a bacterial infection.
• It is recommended to perform a urinalysis in all hospitalized patients or when clinically indicated [1, 12, 18].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Informative for detecting inflammatory changes in the urinary tract in patients with rotavirus infection.
• It is recommended for hospitalized patients with moderate and severe disease to perform a general biochemical blood test (determination of glucose, urea, creatinine, alanine aminotransferase, aspartate aminotransferase, amylase levels) [1, 7, 9, 19].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: This test is informative in patients with moderate and severe rotavirus gastroenteritis to detect complications and determine the severity of the disease.
2.4 Instrumental Diagnostics
• It is recommended to perform an ultrasound examination of the abdominal cavity (comprehensive) when it is necessary to perform differential diagnosis of rotavirus gastroenteritis with other infectious and non-infectious diseases
[9.12] .
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5). Comments: This study is informative for diagnosing complications of the disease.
• It is recommended to perform an electrocardiographic examination in patients with moderate and severe rotavirus gastroenteritis to detect complications [1, 8, 12, 18].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5). Comments: This study is informative for diagnosing cardiovascular complications, especially in the presence of electrolyte disturbances.
2.5 Other Procedures
None provided.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
The choice of treatment method for rotavirus gastroenteritis depends on the clinical picture, disease severity, and presence of complications [2].
3.1 Conservative Treatment
• It is recommended to prescribe oral rehydration to restore water and electrolyte balance (taking into account the child's age and body weight) [20–22].
LeveL of Recommendation AGrade of Evidence 2LeveL of Recommendation A (Grade of Evidence - 2).
Comments: The administration of reduced-osmolarity solutions (225–245 mOsm/L) is indicated until the dehydration syndrome is completely resolved
• It is recommended to perform infusion therapy (if oral rehydration is ineffective) for the purpose of rehydration, detoxification, and correction of water and electrolyte balance using intravenous solutions (B05BB solutions affecting water and electrolyte balance): electrolyte solutions, electrolytes in combination with carbohydrates, and carbohydrates in patients with rotavirus gastroenteritis (taking into account the children's age and indications) [9-11, 20-22].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comments: Parenteral fluid administration is carried out based on physiological requirements, ongoing pathological losses, and the existing fluid deficit.
• It is recommended to prescribe adsorbing intestinal preparations with cytomucoprotective action for pathogenetic therapy in patients with rotavirus gastroenteritis (taking into account the children's age and indications) [9-11].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5). Comments: they are prescribed to children until diarrhea stops [23-25, 26-28].
• It is recommended to prescribe antidiarrheal medications based on diosmectite** in age-appropriate dosages [23-25].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comments: prescribed to children until diarrhea stops. The use of antidiarrheal drugs that reduce the tone and motility of smooth muscles of the intestine, slow down the passage of intestinal contents, and reduce the excretion of fluid and electrolytes with feces is not indicated.
• It is recommended to prescribe antidiarrheal microorganisms (probiotics) with proven efficacy for pathogenetic therapy in patients with rotavirus gastroenteritis (taking into account the children's age and indications) [29-31].
GCR ALEL 1Grade of Recommendation A (Level of Evidence - 1). Comments: Antidiarrheal microorganisms (probiotics) are prescribed in accordance with the instructions, age, and strain composition of the preparation. Clinical efficacy has been proven for Bifidobacterium animalis subsp. lactis, Lactobacillus acidophilus, S. boulardii, and Lactobacillus GG. Antidiarrheal microorganisms are recommended to be prescribed both in the acute phase of the disease and in the convalescence phase [29-31].
• It is recommended in severe rotavirus gastroenteritis or in the presence of concomitant diseases to prescribe antiviral agents (J05AX other antivirals) or immunostimulants (L03A immunostimulants) for pathogenetic therapy in patients with rotavirus gastroenteritis [1, 2, 13].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Preparations of human recombinant #interferon alfa-2b** in suppositories (one suppository twice a day, under the age of seven years - 150,000 IU, over seven years - 500,000 IU, prescribed for at least 5 days), immunostimulants containing affinity-purified antibodies to human gamma-interferon (Anaferon for children), and umifenovir** may be used [32-35].
3.2 Other Treatment
• It is recommended to prescribe diet therapy taking into account the nature of gastrointestinal lesions; patients with rotavirus infection are prescribed a diet option with mechanical and chemical sparing [9–11].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: Diet therapy helps accelerate reparative processes in the affected digestive organs in patients with rotavirus infection. In infants, continuation of breastfeeding is recommended; for formula-fed infants with moderate disease severity, the use of lactose-free/low-lactose breast milk substitutes is recommended, while for severe cases and pronounced malabsorption syndrome, lactose-free protein hydrolysate-based formulas are indicated. In children over 2 years of age, a diet with mechanical and chemical sparing is recommended.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Currently, rehabilitation methods have not been developed for patients with rotavirus infection.
5. Prevention and Dispensary Observation
Preventive measures are aimed at early and active diagnosis and the isolation of patients from organized groups. Requirements for the complex of organizational, therapeutic, sanitary, and anti-epidemic (preventive) measures carried out to prevent the emergence and spread of rotavirus infection are established by the Sanitary Rules SanPiN 3.3686-21 "Sanitary and epidemiological requirements for the prevention of infectious diseases."
Identification of patients with rotavirus infection is carried out by physicians of all specialties, mid-level medical personnel of medical and preventive institutions, health resorts, and other facilities, regardless of departmental affiliation and forms of ownership. Patients with rotavirus infection are subject to mandatory recording and registration in the established manner. Information on each detected case of the disease is transmitted from the medical institution by phone within 2 hours, and an emergency notification is sent within 12 hours to the territorial body of the federal executive authority authorized to exercise federal state sanitary and epidemiological supervision at the place where the patient was detected (regardless of their place of residence).
Medical observation of contact persons belonging to privileged occupational groups (decreed populations) and children attending preschool educational institutions and summer health camps is carried out not only at their place of residence but also at their place of work (study, recreation).
The results of medical observation are recorded in outpatient charts, child development histories, and in inpatient settings—in medical case histories (when an outbreak is registered in a hospital).
The duration of medical observation is 7 days and includes questioning, physical examination, monitoring of stool consistency, and thermometry.
Individuals who have undergone rotavirus infection and do not belong to decreed populations are discharged after clinical recovery. The necessity of their laboratory testing prior to discharge is determined by the attending physician, taking into account the clinical course of the disease and the recovery process.
The duration of follow-up (dispensary observation) is determined by the attending physician.
Specific prophylaxis of rotavirus infection.
• Vaccine prophylaxis of rotavirus infection is recommended, taking into account the high contagiousness of rotavirus infection, the insufficient effectiveness of non-specific preventive measures (sanitary and hygienic measures), and the lack of etiotropic therapy [36–40].
GOR ALE 1Grade of Recommendation A (Level of Evidence - 1). Comments: WHO strongly recommends the inclusion of rotavirus vaccines in national immunization programs worldwide, accompanied by comprehensive nationwide epidemiological and post-marketing surveillance. At the same time, WHO notes that the lack of epidemiological surveillance should not be an obstacle to the introduction of vaccination [41, 44, 45].
When carrying out vaccine prophylaxis of rotavirus infection, one must be guided by current regulatory and methodological documents on the organization of immunization, primarily the National Schedule of Preventive Vaccinations of the Russian Federation and the Schedule of Preventive Vaccinations for Epidemic Indications (Order of the Ministry of Health of the Russian Federation No. 125n dated March 21, 2014, as amended on February 3, 2021), as well as the Instructions for Use of the immunobiological preparation.
Pentavalent live rotavirus vaccine** as a solution in a volume of 2 ml (1 dose) is intended for oral administration only. The vaccination course consists of 3 doses of the pentavalent live rotavirus vaccine (PLRV) with an interval between administrations of 4 to 10 weeks. Administration schedule. The first dose of PLRV is administered at the age of 6 to 12 weeks, which ensures maximum safety for the patient. All three doses are recommended to be administered before the child reaches 32 weeks of age. The efficacy and safety of PLRV have not been established in children younger than 6 weeks and older than 32 weeks of age.
Vaccination against rotavirus infection is carried out within the framework of the Schedule of Preventive Vaccinations for Epidemic Indications (Order of the Ministry of Health of the Russian Federation No. 125n dated March 21, 2014, Appendix No. 2), taking into account the timing of vaccine administration in the National Schedule of Preventive Vaccinations: 1) the vaccination schedule most closely matching the instructions: 1st dose at the age of 2 months simultaneously with the pneumococcal vaccine**; 2nd and 3rd doses at 3 and 4.5 months (or 4.5 and 6 months), respectively, simultaneously with the vaccines of the national schedule. 2) under the 3–4.5–6 months schedule, PLRV can be administered simultaneously with other routine vaccines.
Procedure organization. Vaccination must be carried out in an immunization room equipped with anti-shock therapy supplies, following a preliminary examination of the child by a pediatrician and temperature measurement. After vaccination, the child should remain under observation for at least 30 minutes. In case the child spits out or regurgitates part of the vaccine, administering an additional dose is not recommended, as the altered dosing regimen has not been studied in clinical trials. Remaining doses should be administered according to the vaccination schedule. Feeding the child, giving tea, juices, and other liquids is permissible immediately after vaccination.
6. Organization of Medical Care
Treatment of patients diagnosed with mild to moderate rotavirus infection in the absence of risk factors is carried out on an outpatient basis; severe cases, moderate cases with comorbid conditions or risk factors, as well as cases with epidemiological indications, are treated in an inpatient setting, and life-threatening complications are managed in an intensive care unit (ICU). Hospitalization of identified patients (or patients with suspected acute intestinal infections) and carriers of acute intestinal infection pathogens is carried out according to clinical and epidemiological indications. Patients subject to hospitalization include children under 2 years of age with severe and moderate forms of acute intestinal infections and those with burdened premorbid backgrounds, patients of all ages with severe concomitant diseases, patients with protracted forms of the disease, acute intestinal infection patients with various forms where the anti-epidemic regime cannot be maintained at their place of residence (where the patient was detected), acute intestinal infection patients from decreed populations, and acute intestinal infection patients of various ages housed in closed institutions.
Indications for discharging a patient from a medical organization: купирование of dehydration syndrome, normalization of temperature and stool consistency.
Criteria for Evaluating the Quality of Medical Care
№ | Assessment of performance (yes/no) | |
|---|---|---|
1. | Body weight measurement performed | Yes/no |
2. | Assessment of the degree of dehydration performed, including using the CDS scale for assessing the severity of dehydration | Yes/no |
3. | Complete blood count with differential and hematocrit performed in patients with moderate and severe rotavirus infection | Yes/no |
5. | Etiological diagnostics performed: determination of rotavirus antigens in stool samples (ELISA), or molecular biological testing of stool for rotaviruses (PCR), or immunochromatographic detection of rotavirus antigens | Yes/no |
6. | Oral rehydration performed using oral rehydration solutions (depending on age and type of dehydration) | Yes/no |
7. | Calculation of infusion therapy volume performed in case of infusion therapy administration | Yes/no |
8. | Therapy with medicinal products from the group of intestinal adsorbents performed | Yes/no |
9 | Therapy with antidiarrheal drugs performed | Yes/no |
References
Show references
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Appendix A1. Working Group Composition
Full name of developers | Place of work indicating position, academic degree, and academic title | Work address including postal code | Work telephone with city code | Association memberships | Conflict of interest |
|---|---|---|---|---|---|
Lobzin, Yuri Vladimirovich | President of the Pediatric Research and Clinical Center for Infectious Diseases of the Federal Medical-Biological Agency, Academician of the Russian Academy of Sciences, D.Sc. in Medicine, Professor | 9 Professor Popov St., Saint Petersburg, 197022 | (812)234-60- 04 | Euro-Asian Society of Infectious Diseases; Association of Infectious Diseases Physicians of Saint Petersburg and Leningrad Region | none |
Uskov, Alexander Nikolaevich | Director of the Pediatric Research and Clinical Center for Infectious Diseases of the Federal Medical-Biological Agency, Ph.D. in Medicine, Associate Professor | 9 Professor Popov St., Saint Petersburg, 197022 | (812)234-60- 04 | Euro-Asian Society of Infectious Diseases; Association of Infectious Diseases Physicians of Saint Petersburg and Leningrad Region | none |
Bekhtereva, Maria Konstantinovna | Senior Researcher at the Department of Intestinal Infections, Pediatric Research and Clinical Center for Infectious Diseases of the Federal Medical-Biological Agency, Ph.D. in Medicine | 9 Professor Popov St., Saint Petersburg, 197022 | (812)346-21- 97 | Euro-Asian Society of Infectious Diseases; Association of Infectious Diseases Physicians of Saint Petersburg and Leningrad Region | none |
Komarova, Anna Mikhailovna | Junior Researcher at the Department of Intestinal Infections, Pediatric Research and Clinical Center for Infectious Diseases of the Federal Medical-Biological Agency, Ph.D. in Medicine | 9 Professor Popov St., Saint Petersburg, 197022 | (812)346-21- 97 | Euro-Asian Society of Infectious Diseases; Association of Infectious Diseases Physicians of Saint Petersburg and Leningrad Region | none |
Rychkova, Svetlana Vladislavovna | Head of the Department of Medical Care Organization, FSBI DNIICIB of the FMBA of Russia, D.Sc. in Medicine, Associate Professor | 9 Professor Popov St., Saint Petersburg, 197022 | (812)234-37- 18 | Euro-Asian Society of Infectious Diseases; Association of Infectious Diseases Physicians of Saint Petersburg and Leningrad Region | none |
Full name of developers | Place of work indicating position, academic degree, and academic title | Work address including postal code | Work telephone with city code | Association memberships | Conflict of interest |
|---|---|---|---|---|---|
Mazankova Lyudmila Nikolaevna | Head of the Department of Pediatric Infectious Diseases, FSBEI DPO RMHPE of the Russian Ministry of Health, D.Sc. in Medicine, Professor | 125993, Moscow, Barrikadnaya str., 2/1, build. 1 | +7 (495) 680- 05-99 ext. 900 | National Scientific Society of Infectious Diseases Specialists | none |
Kharit Susanna Mikhailovna | Head of the Department of Specific Prophylaxis of Infectious Diseases, FSBI DNIICIB of the FMBA of Russia, D.Sc. in Medicine, Professor | 9 Professor Popov St., Saint Petersburg, 197022 | (812)346-21- 97 | Euro-Asian Society of Infectious Diseases; Association of Infectious Diseases Physicians of Saint Petersburg and Leningrad Region | none |
The working group members declared no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Methodology Methods used for collecting/selecting evidence: - search in electronic databases.
• Description of methods used for collecting/selection of evidence: 41 - the evidence base for the recommendations includes publications from the Cochrane Library, EMBASE, MEDLINE, Clinicalkey ELSEVIER databases, and the electronic library (www.elibrary.ru). The search depth was 10 years
Methods used to assess the quality and strength of evidence: - expert consensus;
- assessment of significance in accordance with the levels of evidence reliability and levels of recommendation conviction.
Target audience of these clinical guidelines:
1. disinfectologist;
2. infectious disease physician;
3. clinical laboratory diagnostics physician;
4. clinical pharmacologist;
5. general practitioner (family physician);
6. pediatrician;
7. district pediatrician;
8. medical prevention physician;
9. emergency department physician;
10. anesthesiologist and reanimatologist
11. epidemiologist.
Table 1. Scale for assessing the levels of reliability of evidence (LRE) for diagnostic methods
(diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
|---|---|
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for assessing the levels of evidence (LE) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LE | Definition |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Scale for assessing the levels of recommendation validity (LRV) for methods of prevention, diagnostics, treatment, and rehabilitation (preventive,
diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
C | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
• Federal Law No. 323-FZ of November 21, 2011, "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation" (as amended on December 22, 2020);
• Federal Law of the Russian Federation No. 326-FZ of November 29, 2010, "On Compulsory Medical Insurance in the Russian Federation" (as amended on February 24, 2021);
• Federal Law of the Russian Federation No. 52-FZ of March 30, 1999, "On the Sanitary and Epidemiological Welfare of the Population" (as amended on July 13, 2020);
• Order of the Ministry of Health and Social Development of Russia No. 521n of May 5, 2012, "On Approval of the Procedure for Providing Medical Care to Children with Infectious Diseases", registered with the Ministry of Justice of the Russian Federation on July 10, 2012, Registration No. 24867 (as amended on February 21, 2020);
• Order of the Ministry of Health of Russia No. 804n of October 13, 2017, "On Approval of the Nomenclature of Medical Services", registered with the Ministry of Justice on November 7, 2017, Registration No. 48808 (as amended on March 24, 2020);
• Order of the Ministry of Health and Social Development of Russia No. 541n of July 23, 2010, "On Approval of the Unified Qualification Handbook of Positions of Managers, Specialists, and Employees", section "Qualification Characteristics of Healthcare Sector Employee Positions", registered with the Ministry of Justice of the Russian Federation on August 25, 2010, Registration No. 18247 (as amended on April 9, 2018);
• Sanitary Rules and Norms SanPiN 3.3686-21 "Sanitary and epidemiological requirements for the prevention of infectious diseases";
• Order of the Ministry of Health of the Russian Federation No. 203n of May 10, 2017, "On Approval of Criteria for Assessing the Quality of Medical Care" (registered with the Ministry of Justice of the Russian Federation on May 17, 2017, No. 46740);
• State Report "On the State of Sanitary and Epidemiological Welfare of the Population in the Russian Federation in 2018" Moscow: Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, 2019;
• State Report "On the State of Sanitary and Epidemiological Welfare of the Population in the Russian Federation in 2019" Moscow: Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, 2020;
• State Register of Medicines. Available at: https://grls.rosminzdrav.ru/
• Medical nutrition standards. Methodological guidelines. 2017. Available at: http://cr.rosminzdrav.ru/#!/manuals/adults//
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Rotavirus infection is an acute, highly contagious, anthroponotic infectious disease (meaning the source of infection is a human) with a fecal-oral transmission mechanism caused by rotaviruses; it is characterized by symptoms of general intoxication, gastroenteritis, and dehydration. The fecal-oral transmission mechanism is most commonly realized via the waterborne route (contamination of drinking water by sewage). In this case, children most frequently become infected while swimming in stagnant water bodies (ponds, small pools, etc.) or when using poor-quality water for drinking, cooking, and household needs. The foodborne route of transmission is less significant for rotavirus gastroenteritis and is more commonly realized through the consumption of contaminated milk, dairy products, infant formula, and other products. It should be noted that the contact-transmission (person-to-person) route is particularly significant in families and children's groups.
Children who have suffered severe complications of rotavirus infection may subsequently experience growth and weight retardation.
Vaccination helps prevent rotavirus infection by promoting the development of immunity against rotavirus.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Appendix G1. Dehydration scale designed to objectify the assessment of the degree of dehydration.
Name in Russian: Dehydration Scale
Original title (if available): Clinical Dehydration Scale
Source (official developer website, validation publication): [15]
Type: rating scale
Purpose: objectification of the assessment of the degree of dehydration
Content (template):
Clinical Dehydration Scale (CDS) [15]
Sign | |||
|---|---|---|---|
Score | 1 | 2 | 3 |
General appearance | Normal | Thirst, restlessness, irritability | Lethargy, somnolence |
Eyeballs | Turgor normal | Slightly sunken | Sunken |
Mucous membranes | Moist | Sticky, somewhat dry | Dry |
Tears | Normal tear production | Decreased tear production | Absent tears |
Key (interpretation):
0 points - no dehydration,
1-4 points - mild dehydration,
5-8 points correspond to moderate to severe dehydration