List of Abbreviations
BP – blood pressure
WHO – World Health Organization
GI – gastrointestinal tract
EIA – enzyme immunoassay
Russian Ministry of Health – Ministry of Health of the Russian Federation
ICD-10 – International Statistical Classification of Diseases and Related Health Problems 10th Revision
NVGE – norovirus gastroenteritis
NVI – norovirus infection
OKI – acute intestinal infections
PCR – polymerase chain reaction
FTA – fluorescent treponemal antibody test
ESR – erythrocyte sedimentation rate
FZ – federal law
CNS – central nervous system
RR – respiratory rate
HR – heart rate
ShchD – mechanically and chemically sparing diet
ECG – electrocardiography
CDS dehydration scale (Clinical Dehydration Scale)
Ig M, G – class M, G immunoglobulins
pH – hydrogen ion exponent
Terms and Definitions
Clinical guidelines (treatment protocol) are a regulatory document of the healthcare standardization system that define the requirements for providing medical care to a patient with a specific disease, syndrome, or clinical situation.
Nosological entity – a set of clinical, laboratory, and instrumental diagnostic features that allow the identification of a disease (poisoning, trauma, physiological state) and its classification 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, performance, and ability to adapt to changing environmental conditions (internal and external) while simultaneously altering the body's protective-compensatory and protective-adaptive reactions and mechanisms.
Primary disease – a disease that, by itself or due to complications, creates the primary need for medical care owing to the greatest threat to working capacity, life, and health, or leads to disability, or becomes the cause of death.
Concomitant disease – a disease that has no causal relationship with the primary disease, is secondary to it in terms of the need for medical care, impact on working capacity, and danger to life and health, and is not the cause of death.
Severity of a disease or condition – a criterion determining 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 – the medical and biological consequences of a disease.
Consequences (results) – disease outcomes, as well as the social and economic results of applying medical technologies.
Disease complication – the addition to a disease of a syndrome of physiological process impairment: disruption of the integrity of an organ or its wall; hemorrhage; developing acute or chronic dysfunction of an organ or organ system.
Condition – bodily changes arising from the impact of pathogenic and/or physiological factors that require medical care.
Clinical situation – a case requiring the regulation of medical care regardless of the disease or syndrome.
Syndrome – a condition developing as a consequence of a disease and defined by a set of clinical, laboratory, and instrumental diagnostic features that allow its identification and classification into a group of conditions with different etiologies, but a common pathogenesis, clinical manifestations, and general approaches to treatment, which nevertheless depend on the underlying diseases forming the basis of the syndrome.
Symptom – any sign of a disease that can be determined regardless of the method used for this purpose.
Patient – an individual receiving medical care or applying for medical care, regardless of the presence of a disease and their condition.
Medical intervention – types 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 – a medical intervention or a complex of medical interventions aimed at the prevention, diagnosis, and treatment of diseases, and medical rehabilitation, and having an independent completed significance.
Quality of medical care – a set of characteristics reflecting the timeliness of medical care provision, the correctness of the choice of prevention, diagnostic, treatment, and rehabilitation methods during the provision of medical care, and the degree of achievement of the planned result.
Physiological process – an interrelated aggregate activity of various cells, tissues, organs, or organ systems (an aggregate of functions) aimed at satisfying a vital need of the entire organism.
Function of an organ, tissue, cell, or group of cells – a property constituting a physiological process that implements 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
Norovirus gastroenteritis (A08.1 – acute gastroenteropathy due to Norwalk agent) is an acute, highly contagious infectious anthroponotic disease with a fecal-oral transmission mechanism caused by noroviruses, characterized by the development of gastritis, gastroenteritis, and dehydration syndrome.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Noroviruses belong to the family Caliciviridae, genus Calicivirus, which unites a large group of single-stranded RNA viruses similar in morphology and distinct in antigenic properties, known as "small round structured viruses". The diameter of viral particles is 27 nm. When studied under an electron microscope, 32 cup-shaped depressions are visible on their surface, which is why they were named caliciviruses (from Latin *calyx* – cup) [1–3]. According to modern classification, noroviruses are divided into 7 genogroups (GI, GII, GIII, GIV, GV, GVI, GVII), which unite numerous virus clusters. Norovirus genotypes, in turn, are divided into subgenotypes or genovariants. The most widespread norovirus genogroup is genogroup II, within which 23 genotypes are identified. According to studies conducted in different geographic regions at different times, noroviruses of various genotypes can circulate simultaneously [3, 4].
The mechanism of diarrhea development in norovirus infection has not been sufficiently studied. A decrease in the enzymatic activity of the enterocyte brush border leads to disaccharidase deficiency and the accumulation of an excess amount of non-hydrolyzed carbohydrates, predominantly lactose, in the intestinal lumen. Substances with high osmotic activity (disaccharides and monosaccharides) accumulated in the intestinal lumen lead to impaired reabsorption of electrolytes and water, and the development of osmotic diarrhea. Entering the large intestine, carbohydrates become substrates for fermentation by the intestinal microflora with the formation of a large amount of organic acids, hydrogen, carbon dioxide, and water. The results are increased gas formation in the intestine and a decrease in the pH of the intestinal contents. It has been proven that the level of adenylate cyclase in the small intestinal mucosa does not change. The delayed gastric emptying observed in volunteer studies is likely associated with impaired gastric motor function occurring during infection with this virus [3, 4].
In studies conducted on volunteers infected with noroviruses, an increase in number and shortening of the villi of the proximal small intestine were observed, while the epithelial cells themselves remained intact. Pathological changes in the gastric and duodenal mucosa were not detected, and biopsy during convalescence was normal [2–4]. In all volunteers infected with noroviruses, short-term inflammatory changes in the small intestinal mucosa were described: thickening and shortening of edematous villi of the upper small intestine with mononuclear infiltration of the lamina propria were noted. Cytoplasmic vacuolization and an increase in crypt depth were observed in the apical part of epithelial cells. A decrease in the enzymatic activity of brush border cells was noted. It has been proven that inflammatory changes in the intestinal mucosa do not play a key role in the development of diarrhea, since it occurs even at low viral load levels before the development of cytopathological changes. Following a norovirus infection, unstable (lasting several months) strain-specific immunity is formed, which is why repeated illnesses are possible.
1.3 Epidemiology of the Disease or Condition
Noroviruses are the main cause of acute gastroenteritis outbreaks worldwide. The infection is registered in the form of sporadic cases, group cases, and mass outbreaks; it is believed that the real number of sporadic cases is 300 times higher than the registered number [5, 6]. Following the initiation of mass vaccination against rotavirus infection, noroviruses rank first in the etiological structure of acute intestinal infections (AII) in developed countries. In 2019, according to the State Report on the territory of the Russian Federation, norovirus infection (NVI) was the most common among acute intestinal infections of deciphered etiology. After a significant decline during the COVID-19 pandemic, the incidence rate of norovirus infection (NVI) in the Russian Federation continued to grow in 2023. The incidence rate was 34.51 per 100,000 population, which is 15.12% higher than in 2022 and 2 times higher than the multiannual average (17.39). The proportion of children under 17 years of age in the age structure accounted for 84.4% of all reported cases.
The source of infection is exclusively a sick person or a virus carrier. The infectious dose is only 10–100 viral particles. The infection spreads via water, food, and contact-household routes. Caliciviruses are detected in numerous food products: seafood (especially bivalve mollusks), fresh berries and vegetables, poultry, meat, and bakery products. It should be assumed that a portion of acute intestinal infection outbreaks of unknown etiology occurring as bacterial food poisoning are not bacterial in nature, but rather noroviral.
Equally relevant is the waterborne transmission route. Due to the high resistance of noroviruses to disinfectants and the low infectious dose, accumulation and multiplication of the virus occur in drinking water sources, leading to outbreak morbidity. When outbreaks develop in groups and families, as well as in healthcare facilities, the infection is transmitted mainly via the contact-household route (up to 85% of cases) [5, 6].
Norovirus infection is characterized by pronounced seasonality – an increase in incidence in the autumn-winter period, peaking by December, which is why in English-language literature NVGE is referred to as "winter vomiting disease".
Only GI, GII, and GIV genotypes are pathogenic to humans, with the GII genotype occurring 10 times more frequently than the others. Phylogenetic analysis of noroviruses isolated in different countries has demonstrated the dominance of a single norovirus genovariant simultaneously across almost the entire world. The evolutionary mechanisms driving the persistence and emergence of new norovirus strains in the human population are currently unknown. Evolutionary processes occurring in norovirus populations are compared to the evolution of the influenza virus, which also occurs through antigenic drift and genome segment reassortment.
The peak of norovirus excretion occurs in the acute period of the disease (106 viral copies per 1 g of feces), followed by prolonged (up to 7 weeks) excretion of noroviruses (in the amount of 103 viral copies per 1 g of feces). Prolonged (up to 119–182 days) norovirus excretion has been described in immunocompromised patients without clinical symptoms of the disease [1–3].
1.4 Features of Coding the Disease or Condition
A08.1 – Acute gastroenteropathy due to norovirus.
1.5 Classification of the disease or condition
There is no universally accepted classification of NVI. A classification indicating the type, severity, and course of the disease is used.
By type: typical (manifest form); atypical (latent form, or carrier state)
By form: monoinfection; combined form (with other infectious diseases)
By severity: mild form, moderate form, severe form.
By the presence of complications: uncomplicated, complicated.
By clinical course: acute (up to 14 days); chronic [1].
1.6 Clinical presentation of the disease or condition
The incubation period for norovirus infection lasts from several hours to 1–3 days, most commonly 12–24 hours. A short incubation period (4–12 hours) is frequently observed during outbreaks in confined spaces (airliners, cruise ships, hotels, etc.). The main symptoms of norovirus gastroenteritis are general intoxication (fever, lethargy, vomiting, headache) and gastrointestinal tract (GIT) disorders: abdominal pain, repeated vomiting, and loose stools.
Norovirus gastroenteritis is characterized by two onset variants: acute (about 95% of patients), when all main symptoms appear on the 1st day of the disease, and subacute, when diarrhea and fever join 1–2 initial symptoms (most commonly abdominal pain and vomiting) on the 2nd day of the disease [7, 8].
General infectious syndrome. Norovirus gastroenteritis is characterized by moderately severe intoxication syndrome, lethargy, malaise, weakness, decreased appetite, and in young children, restlessness. The disease usually begins acutely, with temperature often rising to 38–39°C. The febrile reaction can vary in severity, but is most often short-lived.
Syndrome of local changes. Gastrointestinal involvement is the leading symptom of norovirus gastroenteritis and is characterized by intense abdominal pain and vomiting syndrome. Norovirus gastroenteritis typically develops in the manner of «bacterial food poisoning»: hyperacute onset, abdominal pain, and repeated vomiting. In nearly half of patients, diarrheal syndrome is absent or minimally expressed. On the first day of the illness, stool may be formed, then becomes mushy or liquid, and normal stool consistency is restored by days 3–4. Gastrointestinal involvement can present as gastritis, gastroenteritis, or enteritis syndrome. The duration of vomiting is 1–2 days, and diarrhea ranges from 1–2 days to 3–4 days.
By the course type — smooth and non-smooth, including with exacerbations and relapses. Norovirus gastroenteritis in early-age children has certain features. The onset of the disease is usually gradual, enteritic syndrome predominates compared to older children, and dehydration syndrome develops rapidly. The severity of the child's condition is caused by microcirculatory disorders and water-electrolyte balance disturbances.
Complications. Complications of norovirus gastroenteritis are divided into specific and non-specific. Specific complications include: dehydration syndrome and hypovolemic shock, cardiomyopathy, hepatitis, pancreatitis, and central nervous system (CNS) damage. Non-specific complications are usually caused by the development of intercurrent diseases (urinary tract infection, pneumonia, otitis media).
In a typical case, norovirus gastroenteritis (NVGE) is characterized by a benign cyclic course and the presence of a symptom complex specific to this disease (vomiting syndrome), as well as the detection of norovirus antigen in feces via enzyme immunoassay or the detection of norovirus nucleic acids in feces. Mild and subclinical forms proceed with mildly expressed and rapidly passing symptoms, and are diagnosed predominantly in epidemic foci. The asymptomatic form occurs without clinical symptoms of the disease, but with an increase in specific antibody titers in the blood, and is detected in infection foci. Norovirus carriage can be convalescent (after suffered NVGE), or transient (detected in healthy individuals in foci of infectious diarrhea) [7-8].
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for establishing the diagnosis of NVGE: the diagnosis is established based on epidemiological history, analysis of complaints, clinical examination data, and etiological diagnostics.
2.1 Complaints and Anamnesis
It is recommended for all patients with suspected norovirus infection (NVI) to evaluate epidemiological history data (autumn-winter period, preschool and school age, attending a preschool or educational institution, the epidemic situation in these institutions, staying in crowded places) in order to identify the source of infection [5, 7, 8].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Transmission can occur through contact with NVI patients or norovirus carriers, as well as by consuming water and food contaminated with noroviruses.
It is recommended in all patients with suspected NVI to elicit complaints of repeated vomiting and abdominal pain, taking into account their duration and severity [5, 7, 8].
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
Comments: Repeated vomiting combined with abdominal pain and meteorism is characteristic.
It is recommended in all patients with suspected NVI to clarify signs of dehydration from complaints — decreased diuresis and thirst [5, 7, 8].
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
Comments: The development of dehydration syndrome is characteristic of NVI.
It is recommended in all patients with suspected NVI to identify signs of intoxication (headache, decreased appetite, impaired general well-being) [5, 7-9]
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
Comments: Moderately severe headaches, decreased appetite, lethargy, and nausea indicate the development of intoxication in patients with NVI.
2.2 Physical Examination
Physical examination findings are described in the section «Clinical Presentation».
It is recommended in all patients with suspected NVI to measure body temperature (general thermometry) in the morning and evening to monitor the course of the disease [10-12].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: An increase in body temperature in NVI above 400°C and/or persistence of fever for more than 3 days indicate the possible development of complications.
It is recommended in all patients with suspected NVI to measure heart rate (heart rate — HR), respiratory rate (RR), and blood pressure (BP) on peripheral arteries to assess cardiovascular system function [10-12, 13, 14].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: Changes in heart rate, respiratory rate, and blood pressure may indicate the development of complications.
It is recommended in all patients with suspected NVI to measure body weight in order to assess the body's water balance [10-12, 13, 14].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: body weight loss is possible with the development of dehydration syndrome.
It is recommended in all patients with suspected NVI to assess the degree of dehydration, including using the CDS scale (Appendix G1) to decide on the choice of rehydration method [10-12, 13-15].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: The development of dehydration syndrome of varying degrees is characteristic of NVI.
2.3 Laboratory Diagnostics
At the diagnostic stage:
It is recommended for all patients with suspected NVI to perform a coprological fecal examination to assess digestive function and the presence/absence of signs of inflammation [5, 13-15].
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
Comments: Coprograms reveal acidic pH, enzymatic disorders, and transparent mucus.
It is recommended for all patients with suspected NVI to perform etiological diagnostics: determination of norovirus antigens (Norovirus) in stool samples (EIA), or molecular biological examination of feces for caliciviruses (noroviruses, sapoviruses) (Caliciviridae (Norovirus, Sapovirus), or rapid immunochromatographic stool testing for norovirus [5, 10-13].
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
Comments: The study 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 [9-13].
It is recommended for all patients with suspected NVI to exclude a bacterial nature of diarrhea: microbiological (cultural) stool examination for aerobic and facultatively anaerobic microorganisms, microbiological (cultural) examination of feces/rectal swab for Yersinia (Yersinia spp.), for the pseudotuberculosis pathogen (Yersinia pseudotuberculosis), or determination of campylobacter and salmonella antigens in feces, or rapid immunochromatographic stool testing for Escherichia coli, Campylobacter spp., and Salmonella spp. [9-13].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: The study 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.
It is recommended for all patients with NVI with grade I-II, II, or II-III dehydration to perform a blood electrolyte test: blood potassium and sodium levels [9-11].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: The study is informative for diagnosing electrolyte disorders in NVI and must be performed before starting infusion therapy.
It is recommended for all patients with NVI to perform a complete (clinical) blood count with differential leukocyte count (leukocyte formula) and hematocrit evaluation in patients with moderate and severe NVI [9, 10, 11-14].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: The study is informative for diagnosing a non-smooth course of NVI; however, detecting leukocytosis and neutrophilia in the complete (clinical) blood count does not indicate the presence of a bacterial infection.
It is recommended to perform a urinalysis in patients with moderate and severe NVI or when urinary system involvement is suspected [11-14].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: Informative for detecting inflammatory changes in the urinary tract in patients with NVI.
It is recommended to perform a general biochemical blood test in hospitalized patients with NVI (study of blood glucose level, serum C-reactive protein level, blood urea and creatinine levels, determination of alanine aminotransferase, aspartate aminotransferase, and amylase activity in the blood) [11-14].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: The study is informative in patients with moderate and severe NVGE to identify complications and determine the severity of the disease.
2.4 Instrumental Diagnostics
It is recommended to perform a comprehensive ultrasound examination of the abdominal organs if it is necessary to perform differential diagnosis of viral gastroenteritis caused by norovirus (NVGE) with other infectious and non-infectious diseases [10-12, 13, 14].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: The study is informative for the diagnosis of the disease and differential diagnosis with surgical pathology.
It is recommended to perform an electrocardiographic study (registration of an electrocardiogram with decoding, description, and interpretation of electrocardiographic data) in patients with moderate and severe NVGE to identify complications [10, 17, 18].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: The study is informative for diagnosing cardiovascular complications.
2.5 Other Procedures
Not used
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
The choice of treatment method for NVGE depends on the clinical presentation, severity of the disease, and presence of complications [10-12, 18, 19].
3.1 Conservative Treatment
It is recommended to prescribe oral rehydration (oral rehydration salts) to all patients with norovirus infection to restore water-electrolyte balance (taking into account the age and body weight of children) [20-22].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
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 (in case of ineffectiveness of oral rehydration) for the purpose of rehydration, detoxification, and correction of water-electrolyte balance using intravenous solutions (B05BB solutions affecting water-electrolyte balance): electrolyte solutions, electrolytes in combination with carbohydrates, carbohydrates, in patients with rotavirus gastroenteritis (taking into account the age of children 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 intestinal adsorbents with cytomucoprotective action to all patients with norovirus infection for pathogenetic therapy (taking into account the age of children and indications) [10-13, 22].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: prescribed to children until diarrhea stops [23-25, 26-28].
It is recommended to prescribe drugs of the A07BC group – other intestinal adsorbents based on diosmectite** in age-appropriate dosages to patients with norovirus infection in case of diarrheal syndrome [22-25].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comments: prescribed to children until diarrhea stops. The use of antidiarrheal drugs (A07D drugs reducing gastrointestinal motility) that reduce the tone and motility of the 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 to all patients with norovirus infection for pathogenetic therapy (taking into account the age of children and indications) [29-31].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comments: Antidiarrheal microorganisms (probiotics) are prescribed in accordance with the instructions, age, and strain composition of the drug. Clinical efficacy has been proven for Bifidobacterium animalis subsp. lactis, Lactobacillus acidophilus, S. boulardii CNCM I-745, and Lactobacillus GG. It is recommended to prescribe antidiarrheal microorganisms both in the acute phase of the disease and in the convalescence phase [29-31].
It is recommended to prescribe antiviral agents (J05AX other antiviral drugs) or immunostimulants (L03A immunostimulants) for pathogenetic therapy in patients with severe norovirus infection or in the presence of comorbid conditions [7, 15, 18, 31-33, 34].
LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).
Comments: Human recombinant #interferon alfa-2b suppositories can be used (one suppository rectally twice a day, 150,000 IU for children under seven years of age, prescribed for at least 5 days), immunostimulants containing affinity-purified #antibodies to human gamma interferon in children from 6 months of age, or immunostimulants containing affinity-purified #antibodies to human gamma interferon, CD4, and histamine in children from 6 months of age, and #umifenovir** [31-33, 34, 35].
It is recommended to use antiemetic drugs in patients with norovirus infection in case of repeated and/or multiple vomiting to reduce the volume of pathological fluid losses in NVGE [9-11, 36, 37].
LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).
3.2 Diet therapy
Diet therapy is recommended taking into account the nature of gastrointestinal lesions; a diet option with mechanical and chemical sparing is prescribed to patients with norovirus infection to ensure the regeneration of the gastrointestinal mucosa [12, 13, 34].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)
Comments: Diet therapy helps accelerate reparative processes in the affected digestive organs in patients with gastrointestinal salmonellosis. In infants, it is advisable to maintain breastfeeding; in formula-fed infants with moderate disease severity, lactose-free/low-lactose breast milk substitutes or fermented milk formulas can be used; in severe disease severity and pronounced malabsorption syndrome, lactose-free protein hydrolysate-based formulas (in the presence of lactase deficiency) should be used. In children over 2 years of age, a diet with mechanical and chemical sparing is prescribed
3.3 Other Treatment
It is recommended to carry out measures aimed at preventing pain associated with medical procedures in children [38].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)
Comments: medicines for the prevention of pain associated with procedures/medical manipulations may be used : application of topical local anesthetics (cream/patch) 1 hour before the procedure (when placing a peripheral catheter, etc.)
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Currently, rehabilitation methods have not been developed for patients with norovirus infection.
Acute infectious diseases are a contraindication for sanatorium-resort treatment.
5. Prevention and Dispensary Observation
Preventive measures are aimed at early and active diagnosis and isolation of patients from organized groups. Requirements for the complex of organizational, therapeutic, preventive, and sanitary-anti-epidemic (preventive) measures carried out to prevent the occurrence and spread of norovirus infection are established by the Sanitary Rules SanPiN 3.3686-21 "Sanitary and epidemiological requirements for the prevention of infectious diseases".
Detection of patients with norovirus infection is carried out by doctors of all specialties and mid-level medical personnel of medical organizations (MO), health resort facilities, and other institutions, regardless of departmental subordination and forms of ownership. Patients with norovirus infection are subject to mandatory accounting and registration in the established manner. Information about each detected case of the disease is transmitted from the medical organization 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 of detection of the patient (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 records, child development histories, and in hospitals – in case histories (when an outbreak is registered in a hospital).
The duration of medical observation is 7 days and includes an interview, examination, monitoring of stool consistency, and general thermometry.
Individuals who have had norovirus infection and do not belong to decreed occupational groups are discharged after clinical recovery. The need for their laboratory testing before discharge is determined by the attending physician, taking into account the clinical course of the disease and the recovery process.
Dispanserization (follow-up) observation of children who have had norovirus infection is 1 month.
6. Organization of Medical Care
Treatment of patients diagnosed with mild to moderate norovirus infection in the absence of risk factors is carried out on an outpatient basis; severe or moderate cases with concomitant diseases or risk factors, as well as for epidemiological indications, are treated in a hospital setting; when life-threatening complications develop, treatment is provided in an intensive care unit (ICU).
Hospitalization of detected patients (patients with suspected acute intestinal infections) and carriers of acute intestinal infection pathogens is carried out according to clinical and epidemiological indications.
Hospitalization is indicated for patients with severe and moderate forms of acute intestinal infections in children under 2 years of age and in children with burdened premorbid background, patients of all ages with severe comorbidities, patients with prolonged forms of the disease, patients with various forms of acute intestinal infections when it is impossible to comply with the anti-epidemic regime at the place of residence (detection of the patient), patients with acute intestinal infections from among decreed occupational groups, and patients with acute intestinal infections of various ages in closed institutions.
Children are hospitalized in infectious disease hospitals/departments/beds. The hospital must have an intensive care unit, as the condition of children with severe manifestations of norovirus infection can deteriorate sharply.
Indications for discharging a patient from a medical organization: relief of dehydration syndrome, normalization of body temperature, and stool consistency.
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance evaluation |
|---|---|---|
1. | Body weight measurement performed | Yes/no |
2. | The degree of dehydration was assessed. | Yes/no |
3. | A complete blood count (CBC) with differential and hematocrit evaluation was performed. | Yes/no |
4. | Etiological diagnosis was performed: detection of norovirus antigens in stool samples (ELISA), or molecular biological testing of stool for caliciviruses (noroviruses, sapoviruses) (Caliciviridae (Norovirus, Sapovirus)), or rapid immunochromatographic stool test for norovirus | Yes/no |
5. | Oral rehydration was performed using oral rehydration salts (depending on age and type of dehydration) | Yes/no |
6. | Infusion therapy was performed in cases of ineffective oral rehydration | Yes/no |
7. | Intestinal adsorbents were prescribed | Yes/no |
8. | Prescription of antidiarrheal microorganisms with proven efficacy was performed for pathogenetic therapy in patients with norovirus infection (taking into account the children's age and indications) | Yes/no |
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Appendix A1. Working Group Composition
Lobzin, Yuri Vladimirovich — D.Sc. in Medicine, Professor, Academician of the Russian Academy of Sciences, President of the Pediatric Research and Clinical Center for Infectious Diseases of the Federal Medical-Biological Agency (PRCCID FMBA), President of the Euro-Asian Society for Infectious Diseases, and the Association of Infectious Disease Physicians of Saint Petersburg and Leningrad Region
Zhdanov, Konstantin Valerievich — D.Sc. in Medicine, Professor, Corresponding Member of the Russian Academy of Sciences, Director of the PRCCID FMBA, Member of the Euro-Asian Society for Infectious Diseases, and the Association of Infectious Disease Physicians of Saint Petersburg and Leningrad Region
Uskov, Alexander Nikolaevich — D.Sc. in Medicine, Associate Professor, Advisor to the Director of the PRCCID FMBA, Member of the Euro-Asian Society for Infectious Diseases, and the Association of Infectious Disease Physicians of Saint Petersburg and Leningrad Region
Bekhtereva, Maria Konstantinovna — Ph.D. in Medicine, Senior Researcher at the Research Department of Intestinal Infections, Member of the Euro-Asian Society for Infectious Diseases, and the Association of Infectious Disease Physicians of Saint Petersburg and Leningrad Region
Rychkova, Svetlana Vladislavovna – MD, Associate Professor, Head of the Medical Care Organization Department, Pediatric Research and Clinical Center of Infectious Diseases under the Federal Medical-Biological Agency, Pediatrician
Zakharenko, Sergei Mikhailovich — Ph.D. in Medicine, Associate Professor, Deputy Director of the PRCCID FMBA, Member of the Euro-Asian Society for Infectious Diseases, and the Association of Infectious Disease Physicians of Saint Petersburg and Leningrad Region
Conflict of interest: none
Appendix A2. Methodology for Developing Clinical Guidelines
Methodology Methods used for collecting/selecting evidence: - search in electronic databases.
Description of methods used for evidence collection/selection: 41 — the evidence base for the recommendations includes publications from the Cochrane Library, EMBASE, MEDLINE, ClinicalKey (Elsevier), 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 and grades of recommendation.
Target audience for these clinical guidelines:
disinfectologist;
infectious disease physician;
clinical laboratory diagnostics physician;
clinical pharmacologist;
general practitioner (family physician);
pediatrician;
primary care pediatrician;
medical prevention physician;
admitting department physician;
epidemiologist.
Table 1. Levels of Evidence (LoE) grading scale 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 levels of evidence (LE) for methods of prevention, treatment, and medical rehabilitation, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitation interventions)
LoE | 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 grades of recommendation (GR) for prevention, diagnostic, treatment, and medical rehabilitation methods, including those based on natural therapeutic factors (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) |
B | 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 on 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 Public Health in the Russian Federation";
Federal Law of the Russian Federation No. 326-FZ dated 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 dated 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 dated 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 Russian Ministry of Health No. 804n dated 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, with rev. dated October 26, 2022);
Order of the Ministry of Health and Social Development of Russia No. 541n dated July 23, 2010, "On Approval of the Unified Qualification Reference Book of Posts of Managers, Specialists, and Employees", section "Qualification Characteristics of Healthcare Worker Posts", registered with the Ministry of Justice of the Russian Federation on August 25, 2010, Registration No. 18247 (as amended on April 9, 2018);
Resolution of the Chief State Sanitary Doctor of the Russian Federation No. 4 dated January 28, 2021 (as amended on May 25, 2022), "On Approval of Sanitary Rules and Norms SanPiN 3.3686-21 'Sanitary and Epidemiological Requirements for the Prevention of Infectious Diseases'" (including "SanPiN 3.3686-21. Sanitary Rules and Norms...") (Registered with the Ministry of Justice of Russia on February 15, 2021, No. 62500);
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. (In Russ.)
On the state of sanitary and epidemiological welfare of the population in the Russian Federation in 2022: State Report. Moscow: Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing; 2023. 368 p. (In Russ.)
On the State of Sanitary and Epidemiological Welfare of the Population in the Russian Federation in 2023: State Report. Moscow: Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, 2024. – 364 p.
State Register of Medicines. Available from: https://grls.rosminzdrav.ru/
Therapeutic nutrition standards. Methodological guidelines. 2017. Available from: http://cr.rosminzdrav.ru
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Norovirus gastroenteritis is an acute, highly contagious anthroponotic infectious disease with a fecal-oral transmission mechanism caused by noroviruses, characterized by the development of gastritis or gastroenteritis and dehydration; this disease is known as "winter vomiting disease".
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 contract the infection while swimming in stagnant water bodies (ponds, small pools, etc.), or when using unsafe water for drinking, cooking, and household needs. The foodborne transmission route is significant for norovirus gastroenteritis and is most commonly realized through the consumption of contaminated milk, dairy products, infant formula, and other products. It should be noted that the contact-transmission (household) route is particularly significant in families and organized children's groups.
The primary method for preventing norovirus gastroenteritis is strict adherence to personal hygiene rules. If a family member has an intestinal infection, it is especially important to follow sanitary and hygienic rules meticulously: wash hands as frequently as possible, perform daily wet cleaning in the patient's room using disinfectants, thoroughly treat "common areas" or a toddler's potty with detergent complexes; provide the patient with separate toys, utensils, linens, and towels, and change bed linen more often. The patient's laundry must be washed at a water temperature above 60◦C, and it is advisable to iron the washed clothes and linens. These simple measures will help prevent other family members from falling ill.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Appendix G1. Clinical Dehydration Scale (CDS) (Clinical Dehydration Scale)
Russian name: Clinical Dehydration Scale (CDS)
Original name (if applicable): Clinical Dehydration Scale
Source (official developer website, validation publication): Goldman R. D., Friedman J. N., Parkin P. C. Validation of the clinical dehydration scale for children with acute gastroenteritis // Pediatrics. – 2008. – Vol. 122. – No. 3. – P. 545-549, Jauregui J. et al. External validation and comparison of three pediatric clinical dehydration scales // PLoS One. – 2014. – Vol. 9. – No. 5. – P. e95739.
Type (underline): - rating scale
Purpose: assessment of dehydration severity in children
Content (template):
Sign | Score | ||
|---|---|---|---|
0 | 1 | 2 | |
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 |
Scoring key (interpretation): 0 points – no dehydration; 1 to 4 points – mild dehydration; 5–8 points correspond to moderate to severe dehydration