List of Abbreviations
PID – pelvic inflammatory disease
HIV – human immunodeficiency virus
PID – inflammatory diseases of the rectum and anal canal
LGV – lymphogranuloma venereum
DNA – deoxyribonucleic acid
STI – sexually transmitted infections
EIA – enzyme immunoassay
NAAT – nucleic acid amplification tests (synonym: molecular biological studies)
ICD – International Classification of Diseases
MSM – men who have sex with men
PCR – polymerase chain reaction
ReA-STI – sexually acquired reactive arthritis
RCT – randomized controlled trial
RNA – ribonucleic acid
** – the drug is included in the VLDN list
# – off-label (prescription of a drug for unapproved indications)
Terms and Definitions
Sexually transmitted infections (STIs) - a group of diseases which, in accordance with the International Statistical Classification of Diseases and Related Health Problems Tenth Revision (ICD-10), include: syphilis, gonococcal and urogenital chlamydial infections, urogenital trichomoniasis, anogenital herpesviral infection, anogenital (venereal) warts, granuloma inguinale (donovanosis), chancroid, and chlamydial lymphogranuloma (venereal).
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
In these clinical guidelines, as in modern domestic and international scientific and practical literature, the established term for lymphogranuloma venereum is used: "Lymphogranuloma venereum".
Lymphogranuloma venereum (LGV) is a sexually transmitted bacterial infection caused by Chlamydia trachomatis belonging to serovars L1, L2, and L3.
Other known synonyms for LGV include: fourth venereal disease, Durand-Nicolas-Favre disease, tropical bubo.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Chlamydia trachomatis serovars L1, L2, L3 (C. trachomatis (L1-L3)) is an obligate intracellular bacterium transmitted through sexual contact. Chlamydial infection caused by C. trachomatis (L1-L3) does not lead to the development of lasting immunity [1].
C. trachomatis (L1-L3) belongs to the genus Chlamydia (phylum Chlamydiae, order Chlamydiales, family Chlamydiaceae, genus Chlamydia, which, in addition to the species trachomatis, includes 11 other species that are pathogens of humans and animals [2,3].
C. trachomatis is generally subdivided into three biovars: the trachoma biovar, including serovars A, B, C (C. trachomatis (A-C)); the urogenital biovar, including serovars D, E, F, G, H, I, J, K (C. trachomatis (D-K)); and the LGV biovar, including serovars L1, L2, L3 (C. trachomatis (L1-L3)). The term "urogenital biovar" is somewhat conventional, since serovars D-K also cause extragenital manifestations such as pharyngitis, proctitis, conjunctivitis, etc. These guidelines outline the clinical, diagnostic, therapeutic, and preventive aspects of chlamydial infection caused exclusively by LGV biovars of C. trachomatis.
Transmission of C. trachomatis (L1-L3) occurs through direct mucosal contact between individuals during sexual contact (vaginal, oral, or anal), but unlike serovars D-K, which predominantly affect only the mucous membranes of infected anatomical sites, C. trachomatis serovars L1-L3 are highly invasive and capable of invading submucosal connective tissues and disseminating to regional lymph nodes.
The proportion of LGV among other erosive and ulcerative diseases of infectious etiology ranges from 2% to 10% in Southeast Asia and Africa [4]. In economically developed countries, LGV is considered endemic among men who have sex with men (MSM), particularly HIV-positive MSM, among whom HIV prevalence ranges from 67% to 100% [5]. The anorectal form of LGV among MSM occurs 15 times more frequently than the genital form, which can be explained by a more frequent symptomatic course of the disease specifically when the anorectal region is involved, whereas inoculation of the LGV pathogen into the urogenital organs is frequently asymptomatic [6]. Among women and heterosexual men, cases of LGV are casuistic in nature, and evidence of stable LGV circulation among heterosexual men and women is lacking [7,8,9]; therefore, these guidelines focus more heavily on MSM.
1.3 Epidemiology of the Disease or Condition
LGV, initially an endemic disease in countries with tropical and subtropical climates, was not registered in Europe and North America until 2003 [10]. Since the first described cases, LGV has acquired the character of a widespread disease in European countries among MSM and is a frequent cause of proctitis and other inflammatory diseases of the anal canal and rectum (IDACR), though it is very rarely identified as a cause of genital or oropharyngeal diseases [6,11]. Over the years of monitoring LGV in Europe, numerous genetic subvariants of C. trachomatis have been detected, but the L2 and L2b serovariants predominate in most clinical cases, presumably introduced into Europe from the USA in the early 2000s and spread among the European MSM population [12,13].
In the Russian Federation, there is no registration system for LGV among the population. At the same time, 2,389 cases were registered in Europe in 2018, with the highest incidence rates in the United Kingdom, France, and the Netherlands. It should be noted that since 2004, a steady increase in the number of LGV cases has been observed in European Union countries [14].
Comparisons between countries are significantly affected by differences in surveillance systems, diagnostic methods used, the availability and mass scale of testing and screening (national screening programs or the opportunity for opportunistic testing), as well as reporting errors.
The main risk factors for C. trachomatis (L1-L3) infection are: belonging to the MSM group, young age (25–35 years), and factors such as HIV infection, a history of sexually transmitted infections (STIs) including syphilis, infrequent use of barrier contraception, and having multiple regular sexual partners [15,16,17].
1.4 Features of Coding the Disease or Condition
In accordance with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10), the following forms of LGV are distinguished:
A55 Lymphogranuloma (venereum) chlamydial
1.5 Classification of the disease or condition
The following stages of LGV are distinguished [16]:
Primary stage
Secondary stage
Tertiary stage
1.6 Clinical presentation of the disease or condition
Lymphogranuloma venereum (C. trachomatis L1-L3)
In a number of European countries since 2003, LGV has become widespread among MSM, particularly among HIV-positive individuals [18,19]. In 25% of cases, the anorectal form of the disease in MSM is asymptomatic [20,21]. When the genitals are affected, the infection is often transient in nature [9,8,7], and symptoms (papules, erosions) are short-lived. LGV is most frequently detected in MSM with erosive and ulcerative IDACR [22].
The first cases of LGV in the Russian Federation were registered in Moscow in 2019 among MSM seeking medical care from a coloproctologist [23,24].
Depending on the site of pathogen invasion, LGV may manifest as anorectal syndrome (after pathogen inoculation into the rectum) or inguinal region lesions (after pathogen inoculation in the genital or anal region) [11,25].
The incubation period of LGV is 1–4 weeks, followed by three stages of the disease: the primary ulcer stage, the secondary stage with buboes and fistulas, and the tertiary stage of fibrous lymphedema [26].
Anorectal syndrome
Primary stage:
Among MSM, the most frequent manifestation of the primary stage of LGV is proctitis, which is characterized by pronounced anorectal pain, bloody or purulent discharge from the anus, tenesmus, and/or constipation developing against the background of mucosal edema in the terminal sections of the rectum.
Anoscopy reveals granular or hemorrhagic proctitis with purulent exudate, mucosal ulceration, and tumor-like hypergranulations and pseudopolyps. Proctitis is usually not accompanied by clinically apparent inguinal lymphadenopathy, but visualization methods (ultrasound, computed tomography, magnetic resonance imaging) may reveal enlargement of the pelvic lymph nodes.
The clinical manifestations of LGV proctitis typically present with pronounced symptoms, but they must be differentiated from symptoms of autoimmune inflammatory bowel diseases in patients, especially HIV-positive men [6,27,28].
In women, in addition to the rectum, the pathological process may involve the vagina, cervix, and urethra. As a consequence, involvement of the deep lumbar and/or perirectal lymph nodes occurs, manifesting as lower abdominal and lumbar pain. The inguinal and femoral lymph nodes are often unaffected [28].
Secondary stage is characterized by acute lymphadenitis, purulent tissue breakdown, fistula formation, or acute purulent-hemorrhagic (necrotic) proctitis accompanied by systemic symptoms caused by the dissemination of the pathogen throughout the body.
Tertiary stage.
The tertiary stage of the disease in MSM and women manifests as proctocolitis complicated by perirectal abscess, fistulas, strictures, and rectal stenosis. Lymphedema may develop, manifesting as hemorrhoid-like formations resulting from the obstruction of rectal lymphatic vessels. Without treatment, chronic progressive lymphangitis leads to chronic edema and sclerosing fibrosis with the formation of strictures and fistulas in the affected area. Rectal strictures are accompanied by severe pain and constipation, and megacolon may develop [29,30].
Genital symptoms:
Primary stage. Characterized by the appearance of a small painless papule or pustule, which transforms into a small herpetiform ulcer. It usually regresses within 1 week and often goes unnoticed. If rectal infection has occurred, mucopurulent anal discharge may be present.
Secondary stage. 2–6 weeks after the appearance of the primary lesion, painful inguinal-femoral lymphadenopathy develops. Unilateral enlargement and inflammation of the lymph nodes occur with abscess formation. Such buboes may fluctuate and spontaneously rupture in one-third of patients.
Tertiary stage.
As inflammatory phenomena progress, the lymph nodes fuse into conglomerates, and the purulent contents spontaneously rupture through the node capsules. The inflammatory process progresses over several months, leading to further formation of fibrous tissue that obstructs lymphatic vessel patency. Prolonged edema and sclerosing fibrosis cause induration, hypoxia, and enlargement of the affected tissues and organs. Development of genital elephantiasis with ulceration of edematous tissues is possible [31].
In MSM, genital symptoms are rarely observed [32].
In some cases, complications such as sexually acquired reactive arthritis (SARA), meningitis, and inflammatory diseases of eye structures may develop [29,33].
Rare septic complications include: arthritis, pneumonia, perihepatitis [29,33,34].
Treatment in the early stages of the process prevents the development of late complications.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Diagnostic criteria.
The diagnosis of LGV is based on anamnestic data, evaluation of subjective (complaints) and objective symptoms of the disease, and the detection of C. trachomatis (L1–L3) in biological material using molecular biological methods.
Indications for laboratory testing for LGV: [29,35].
belonging to the MSM group;
symptoms of proctitis in men (especially) and women;
presence of risk factor(s) for C. trachomatis (L1–L3) infection and/or other STIs (age 25–35 years, new sexual partner within the last year, more than one steady partner);
erosive and ulcerative genital lesions;
rectal stricture, anal fistula, genital elephantiasis;
purulent discharge from the anus;
individuals diagnosed with other STIs and HIV;
sexual contacts with patients having STIs.
2.1 Complaints and Anamnesis
During the initial consultation, it is necessary to ascertain the reason for the visit, the nature of subjective symptoms (patient complaints), as well as anamnestic data.
Complaints.
At the onset of the disease, patients may complain of the appearance of multiple small vesicles, pustules, and papules with a hyperemic halo in the external genitalia area. After a few days, the elements erode and merge, forming a herpetiform ulcer without infiltration, which heals without scar formation.
Upon initial development of anal lesions, particularly in MSM, patients complain of pain in the rectum, painful tenesmus, pain during defecation, purulent and/or bloody discharge from the anus, diarrhea, and abdominal pain. Rectal syndrome may be accompanied by fever, chills, headache, loss of appetite, myalgia, and arthralgia.
In the second and third stages of the disease, patients note enlargement of regional lymph nodes. When erosions and ulcers are located on the genitals, the inguinal lymph nodes are affected; in rectal involvement, the perirectal nodes; in women, the pelvic lymph nodes may be involved in the inflammatory process.
As the pathological process progresses, the lymph nodes sharply increase in size and density, fusing with the subcutaneous tissue; the skin over them becomes red and painful. Genitoanorectal syndrome develops—a severe fistulous-adhesive process in the area of the external genitalia, perineum, and rectum. In women, the rupture of nodes with exudate discharge and fistula formation results in rectovaginal fistulas (communications between the vagina and rectum) [32].
Anamnestic data [35]:
1) history of the present illness: presence of symptoms of acute hemorrhagic, erosive, or necrotic proctitis; time of symptom onset, dynamics of the pathological process, use of systemic and/or local medications for symptoms, presence and nature of symptoms in the sexual partner;
2) personal history: social status, occupational hazards, somatic diseases, allergological history, alcohol consumption, drug use, smoking;
3) sexual history: same-sex sexual contacts, age of sexual debut, marital status, presence/absence of a steady sexual partner, nature of sexual contacts (oral, anal), date of last sexual contact;
4) presence of C. trachomatis DNA in the rectum or other anatomical loci;
5) STI history: history of past STIs, partner's STI history;
6) urological history: past urological diseases, sexual dysfunction, infertility;
7) gynecological history: past gynecological diseases, STIs, infertility;
8) presence of STI and HIV risk factors: age 25–35 years, multiple sexual partners and/or casual sexual contacts without barrier protection, urogenital infections in sexual partners, sexual assault, commercial sex work, homosexuality, drug use, alcohol abuse, homelessness.
2.2 Physical Examination
A physical examination is performed [35]:
1) examination of the skin of the head, trunk, upper and lower extremities, skin appendages, visible mucous membranes, palpation of regional lymph nodes, abdominal palpation;
2) palpation of the scrotal organs and penis, digital rectal examination of the prostate gland and seminal vesicles;
3) bimanual gynecological examination and inspection using a Cusco vaginal speculum; assessment of the state of the urethra, paraurethral and greater vestibular glands.
4) assessment of the minimum criteria for pelvic inflammatory disease (PID).
5) anoscopy and/or sigmoidoscopy, digital rectal examination of the anal canal.
2.3 Laboratory Diagnostics
Laboratory diagnostics of lymphogranuloma venereum
The gold standard for verifying the diagnosis of LGV is molecular biological testing (nucleic acid amplification tests (NAATs)) that identify pathogen-specific nucleic acid sequences (DNA) due to the high sensitivity and specificity of NAATs, as well as their rapid turnaround time [36,37].
Conditions for using NAATs in the diagnosis of LGV:
Reagent kits for qualitative or quantitative detection of Chlamydia trachomatis DNA by PCR, capable of selectively detecting and identifying C. trachomatis nucleic acids (L1–L3) [36,37,38];
NAAT-based reagent kits must be registered in the Russian Federation in accordance with current legislation;
Molecular biological tests are used to detect specific nucleic acid sequences (DNA) of C. trachomatis (L1–L3). Molecular biological methods have the highest sensitivity and specificity compared to other laboratory methods [36,39].
Materials for testing by molecular biological methods may include:
- biological material obtained directly from primary lesions—from the ulcer base or from anogenital loci;
- biological material from the vagina;
- biological material from the urethra;
- first-catch urine samples in men;
- biological material from the rectum (including self-collected in asymptomatic disease course);
- lymph node or bubo aspirates after local disinfection;
- biological material from the oropharynx;
Positive NAAT results can be obtained as early as 1–3 days after C. trachomatis (L1–L3) infection. Patients should be tested at the initial visit; however, if there is doubt about potential infection within the last 2 weeks, the NAAT test should be repeated 2 weeks after sexual contact.
Culture testing does not distinguish C. trachomatis (L1–L3) from other chlamydial serovars, making its use impractical.
Also, biological, chemical, and alimentary provocations are not used in patients to increase the diagnostic and therapeutic efficacy of LGV infection.
It is recommended for all adult patients to undergo microscopic examination of urethral discharge (in men), microscopic examination of vaginal smears, and microscopic examination of rectal discharge to assess the severity of the inflammatory process (number of polymorphonuclear leukocytes) [40,41,65].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Comments: microscopic examination does not detect C. trachomatis, but the method allows for assessing the degree of the inflammatory reaction in the vagina, urethra, and rectum.
It is recommended to conduct a comprehensive examination of all patients with suspected LGV infection to verify the diagnosis and diagnose concomitant pathology [35]:
1) determination of antibodies to Treponema pallidum (Treponema pallidum) by enzyme-linked immunosorbent assay (ELISA) in blood, or determination of antibodies to Treponema pallidum (Treponema pallidum) using non-treponemal tests (RPR, RPR card test) (qualitative and semi-quantitative testing) in blood serum;
2) detection of antibodies to human immunodeficiency virus types 1 and 2 and human immunodeficiency virus type 1 and 2 p24 antigen in blood;
3) detection of hepatitis B virus (Hepatitis B virus) surface antigen (HBsAg) in blood and detection of antibodies to hepatitis C virus (Hepatitis C virus) in blood.
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Comments: tests are performed in accordance with the incubation period for syphilis, hepatitis B, C, and HIV infection, or all sexual partners of the patient are screened for these infections.
It is recommended that patients undergo molecular biological testing of rectal mucous membrane discharge for the diagnosis of chlamydial infection and associated pathology [35-43]:
ᴑ detection of Chlamydia trachomatis (C. trachomatis) DNA with identification of serovars L1-L3 (C. trachomatis (L1-L3)) in rectal mucous membrane discharge by PCR and/or
ᴑ detection of Treponema pallidum DNA in discharge from erosive and ulcerative lesions of the rectal mucosa by PCR and/or
ᴑ detection of herpes simplex virus types 1 and 2 (Herpes simplex virus types 1, 2) DNA in discharge from erosive and ulcerative lesions of the rectal mucosa by PCR and/or
ᴑ detection of Treponema pallidum DNA and herpes simplex virus types 1 and 2 (Herpes simplex virus types 1, 2) DNA in discharge from erosive and ulcerative lesions of the rectal mucosa by PCR and/or
ᴑ detection of Chlamydia trachomatis DNA, Neisseria gonorrhoeae, and Mycoplasma genitalium DNA in rectal mucosal discharge by PCR.
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Comments: in MSM patients, when direct detection of C. trachomatis (L1-L3) DNA is not possible, testing for C. trachomatis DNA without specifying the L1-L3 serovars is permitted. The presence of multiple unprotected anogenital contacts and pronounced clinical symptoms of proctitis in MSM with detected C. trachomatis DNA (without specifying L1-L3 serovars) may indicate the presence of LGV.
It is recommended that all patients undergo verification of the diagnosis of concomitant STIs [1, 16, 41]:
ᴑ molecular biological testing of female genital mucous membrane discharge for Chlamydia trachomatis (Chlamydia trachomatis) or molecular biological testing of female genital mucous membrane discharge for sexually transmitted infection pathogens (Neisseria gonorrhoeae, Trichomonas vaginalis, Chlamydia trachomatis, Mycoplasma genitalium);
ᴑ molecular biological testing of urethral discharge for Chlamydia trachomatis (Chlamydia trachomatis) or molecular biological testing of urethral discharge for sexually transmitted infection pathogens (Neisseria gonorrhoeae, Trichomonas vaginalis, Chlamydia trachomatis, Mycoplasma genitalium).
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
It is recommended that patients have antibodies to Chlamydia trachomatis (Chlamydia trachomatis) determined in the blood for the diagnosis of LGV or ascending infection only when direct detection of C. trachomatis (L1-L3) DNA using molecular biological methods is not possible. It should be borne in mind that high titers of IgA class antibodies to C. trachomatis may indicate the presence of LGV [35].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Comments: serological tests should not be used for screening. In the majority of patients, only highly invasive chlamydial infection (e.g., LGV) leads to an increase in antibody levels to a detectable threshold. It should be noted that only ELISA using synthetic peptides does not yield cross-reactions. Serological tests have limited value in the diagnosis of ascending infection and causes of infertility [42].
It is unknown how long specific anti-chlamydial antibodies persist in the blood; therefore, serological tests should not be used to monitor cure.
2.4 Instrumental Diagnostics
It is recommended that patients undergo anoscopy when rectal involvement is suspected to identify signs of distal erosive and ulcerative proctitis: purulent exudate, mucosal ulceration, presence of tumor-like masses [43, 44].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
2.5 Other Procedures
It is recommended that patients with suspected LGV infection have an initial appointment (examination, consultation) with a dermatovenereologist, as well as, when indicated, consultations with related specialist physicians to verify the diagnosis and determine further management tactics [29, 35].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Comments: consultations with related specialist physicians as indicated:
1) appointment (examination, consultation) with a coloproctologist in the presence of symptoms of anal and rectal inflammation;
2) appointment (examination, consultation) with a urologist in the presence of symptoms of epididymitis;
3) appointment (examination, consultation) with an obstetrician-gynecologist in the presence of symptoms of pelvic inflammatory disease in women, or when managing pregnant women to clarify the diagnosis and management tactics;
4) appointment (examination, consultation) with a surgeon in the presence of relevant clinical symptoms to clarify patient management tactics.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Indications for therapy
Identification of C. trachomatis (L1-L3) DNA in biological material;
Epidemiological indications, if the patient belongs to the MSM social group;
Epidemiological indications – if the sexual partner has been diagnosed with LGV infection;
Epidemiological indications – in the presence of HIV infection;
Epidemiological indications in cases of sexual assault, particularly involving anogenital contact (samples should be obtained for subsequent NAAT testing).
Epidemiological indications – individuals who have had sexual contact (homosexual or heterosexual) with patients with LGV (or individuals with clinical symptoms) during travel to countries with tropical and subtropical climates, as well as countries in Europe or the USA.
3.1 Conservative Treatment
To date, there is no evidence of any stable homotypic or phenotypic resistance of clinical C. trachomatis (L1-L3) strains to any systemically acting antibacterial drugs used for treatment that could affect the efficacy of LGV treatment [45, 46, 47].
Treatment of lymphogranuloma venereum
It is recommended that adult patients being treated for infection caused by C. trachomatis (L1-L3) receive systemic antibacterial drugs to eliminate the pathogen [48-51, 60]:
Doxycycline** 100 mg orally twice daily for 21 days.
GCR CLOCE 4Grade of Recommendation C (Level of Evidence 4)
Comment: doxycycline** should be avoided in the second and third trimesters of pregnancy due to the risk of dental and musculoskeletal abnormalities in the fetus, but it is compatible with breastfeeding [61]. In an open-label clinical trial, #azithromycin** 1,0 g orally weekly for 3 weeks showed clinical and microbiological efficacy comparable to doxycycline** in the treatment of lymphogranuloma venereum presenting as proctitis [66]. #Azithromycin** may be useful for treating LGV during pregnancy, but published data on the effective dose and duration of treatment are lacking.
It is recommended that adult patients being treated for uncomplicated infection caused by C. trachomatis (L1-L3) receive systemic antibacterial drugs to eliminate the pathogen (second-line therapy):
- Erythromycin 500 mg orally 4 times daily for 21 days [50, 51].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Comment: erythromycin should be used during pregnancy. Erythromycin therapy may also be used if there are contraindications to prescribing doxycycline**. There is no evidence that a different therapeutic approach is required in the presence of HIV infection.
It is recommended that adult patients being treated for uncomplicated infection caused by C. trachomatis (L1-L3) receive systemic antibacterial drugs to eliminate the pathogen (as alternative therapy):
- Azithromycin 1,0 g orally once a week for 3 weeks [66].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Comment: azithromycin demonstrated 98% clinical and 97% microbiological efficacy in the treatment of a cohort of 82 HIV-positive MSM.
3.2 Surgical Treatment
It is recommended that patients being treated for LGV, in addition to oral antibiotic therapy, undergo drainage of fluctuating buboes via needle aspiration through intact skin to achieve cure [51, 52].
GCR CLOCE 5Grade of Recommendation C (Level of Evidence 5)
Comments: surgical excision of buboes should not be performed due to the potential formation of purulent fistulas.
Additional antibiotic therapy is not used for patients with residual fibrotic lesions. The necessity of reconstructive surgical procedures should be considered.
3.3 Other Treatment
Pain management and dietary therapy are not used.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable.
5. Prevention and Dispensary Observation
It is recommended to practice primary prevention, which consists of using condoms during all types of sexual contact, reducing the number of sexual partners, and maintaining monogamy [21,29,50,53].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
It is recommended to conduct screening tests in vulnerable groups, primarily MSM, in order to reduce the incidence in the population and prevent complications of LGV infection [54,55].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
Patients with a positive test for C. trachomatis (L1-L3) are recommended to abstain from sexual contact for seven days after they and their partners complete treatment and their symptoms resolve [29,42].
LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)
It is recommended that all patients undergo a clinical and laboratory examination to establish the criteria for cure of LGV. A physical examination and laboratory tests are performed after the treatment (molecular biological tests using PCR 3–4 weeks after the last day of systemic antimicrobial therapy) [56]:
Molecular biological tests:
ᴑ Detection of Chlamydia trachomatis DNA with identification of serovars L1-L3 (C. trachomatis (L1-L3)) in rectal mucosal discharge by PCR;
ᴑ Detection of Chlamydia trachomatis DNA in rectal mucosal discharge by PCR (if C. trachomatis typing is not feasible).
GCR CLOCE 5Grade of Recommendation C (Level of Evidence 5)
It is recommended that patients after LGV treatment undergo microscopic examination of urethral discharge, microscopic examination of vaginal smears (in women), and microscopic examination of rectal discharge to assess the severity of the inflammatory response (number of polymorphonuclear leukocytes). If the source of infection has been identified and laboratory test results for LGV infection are negative, patients do not require further follow-up [56,62].
GCR CLOCE 5Grade of Recommendation C (Level of Evidence 5)
Management of sexual partners of patients with LGV infection
It is recommended to examine and treat all sexual partners from the 6 months preceding the onset of LGV symptoms (or the last sexual partner). The need to examine and treat the sexual partner of a patient with an STI to reduce overall morbidity has been proven for all STIs [63,64].
GCR CLOCE 5Grade of Recommendation C (Level of Evidence 5)
Comments: examining and treating the sexual partner of a patient with an STI is a vital component of any STI control program.
Repeat testing to detect potential reinfection is recommended for young heterosexual men and women (< 25 years old) 3–6 months after completing LGV treatment, as well as for MSM of all ages [40,41].
GCR CLOCE 5Grade of Recommendation C (Level of Evidence 5)
Comments: according to studies, the rate of reinfection with various STIs varies widely, but is particularly high among MSM [57].
6. Organization of Medical Care
Indications for hospitalization in a medical organization:
1) Severe course of LGV (necrotizing ulcerative proctitis, paraproctitis, rectal stricture, fistulae, anal fissures);
2) Dynamic status monitoring in persistent infection for the purpose of instrumental diagnostic methods (as indicated).
Indications for patient discharge from a medical organization:
1) Stabilization of condition;
2) Completion of planned examination;
3) Resolution of clinical manifestations of the inflammatory process;
4) Negative test results for C. trachomatis (L1-L3).
Reporting of diagnosed STI cases
The legislation of the Russian Federation defines STI reporting forms to be completed by physicians of any specialty who diagnose an STI:
Two forms of state statistical observation: No. 9 — "Data on sexually transmitted infections, fungal skin diseases, and scabies" and No. 34 — Order of Rosstat dated December 29, 2011, No. 520 (ed. dated December 24, 2018) "On the approval of statistical tools for the organization of federal statistical observation by the Ministry of Health and Social Development of Russia over the activities of healthcare institutions."
Form No. 089/u-kv — "Notification of a patient with a newly diagnosed case of syphilis, gonococcal infection, trichomoniasis, chlamydial infection, urogenital herpes, anogenital warts, microsporia, favus, trichophytosis, foot mycosis, scabies", approved by the Russian Ministry of Health on March 2, 2015, No. 13-2/25 On accounting form No. 089/u-kv "Notification of a patient with a newly diagnosed case of: syphilis, gonococcal infection, chlamydial infections, trichomoniasis, anogenital herpesviral infection, anogenital (venereal) warts, mycosis, scabies", sent within 3 days to the territorial dermatovenereological dispensary. The territorial dermatovenereological dispensary forwards the received notifications to the head dispensary of the subject of the Russian Federation monthly no later than the 5th day of the month following the reporting month.
Employees of institutions receiving this information are legally responsible for ensuring information confidentiality and maintaining medical secrecy.
7. Additional Information
Requirements for obtaining biological material for laboratory testing in the diagnosis of LGV infection.
To obtain reliable laboratory results, a number of requirements must be met, including:
timing of obtaining biological material taking into account the administration of medications: (molecular biological tests — in 3–4 weeks using PCR);
obtaining biological material from the rectal mucosa without fecal contamination using sterile swabs;
compliance with the conditions for sample delivery to the laboratory.
For laboratory testing in men in the diagnosis of LGV, the following is used:
biological material of rectal mucosal discharge (primarily);
first-catch urine;
as indicated — biological material from the oropharynx, surfaces of the glans and shaft of the penis, eye conjunctiva, etc.
In homosexual men, as well as among other vulnerable groups, coinfection with other STIs at various anatomical sites is possible. In such cases, simultaneous sampling from the anus/rectum, urine/urethral biological material, and oropharynx is indicated.
For laboratory testing in women in the diagnosis of LGV, the following is used:
biological material from the urethra, cervical canal, vagina (self-collection of vaginal material is possible);
as indicated — biological material from the rectum, oropharynx, eye conjunctiva;
molecular biological testing of first-catch urine in women has sub-optimal sensitivity and should only be used if obtaining other biological material is not feasible.
Factors affecting therapy efficacy:
The efficacy of LGV therapy may be reduced in the presence of adverse drug reactions such as vomiting or diarrhea.
The outcome of the disease is also influenced by patient compliance, i.e., strict adherence to the physician's recommendations regarding the frequency of antimicrobial administration and the duration of the treatment course. Low patient compliance is associated with younger age and a history of treatment courses for chlamydial infection [58].
Identification and treatment of the patient's sexual partners reduces the likelihood of reinfection [4,35,59].
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance assessment (yes/no) |
|---|---|---|
1 | Initial appointment (examination, consultation) with a dermatologist-venereologist performed | Yes/no |
2 | Molecular biological testing of female genital mucosal discharge / urethral discharge for Chlamydia trachomatis (Chlamydia trachomatis) performed | Yes/no |
3 | Prescription of systemic antibacterial therapy (in the absence of contraindications) | Yes/no |
References
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Appendix A1. Working Group Composition
1. Potekaev N.N. — Doctor of Medical Sciences, Professor, President of the LLC "National Alliance of Dermatovenereologists and Cosmetologists", Member of the European Union against STIs (IUSTI/WHO), Honorary President of the Euro-Asian Association of Dermatovenereologists (EAAD), Member of the Board of Directors of the European Academy of Dermatology and Venereology (EADV), Corresponding Member of the German Dermatological Society (DDG), Honored Worker of Healthcare of the Russian Federation, Chief freelance specialist in dermatovenereology and cosmetology of the Russian Ministry of Health, Chief freelance specialist in dermatovenereology and cosmetology of the Moscow Healthcare Department, Director of the SBIH "Moscow Center for Research and Practice in Dermatovenereology and Cosmetology of the MHD", Head of the Department of Skin Diseases and Cosmetology at the Faculty of Continuing Professional Education of the Pirogov Russian National Research Medical University of the Russian Ministry of Health.
2. Gomberg, M.A. – Doctor of Medical Sciences, Professor, President of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Member of the Royal College of Physicians (RCP), Member of the American Academy of Dermatology (AAD), Member of the European Academy of Dermatology and Venereology (EADV), Senior Advisor to the International Union against Sexually Transmitted Infections (IUSTI), Member of the National Alliance of Dermatovenereologists and Cosmetologists, Chief Researcher, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
3. Gushchin, A.E. – Candidate of Biological Sciences, Member of the Microbiology Committee of the Federation of Laboratory Medicine, Member of the European Union against STIs (IUSTI/WHO), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Member of the National Alliance of Dermatovenereologists and Cosmetologists, Leading Researcher, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
4. Dmitriev, G.A. – Doctor of Biological Sciences, Professor, Member of the National Alliance of Dermatovenereologists and Cosmetologists, Full Member of the Russian Academy of Natural Sciences (RANS), Member of the European Union against STIs (IUSTI/WHO), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Chief Researcher, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
5. Dolya, O.V. – Doctor of Medical Sciences, Member of the National Alliance of Dermatovenereologists and Cosmetologists, Member of the European Union against STIs (IUSTI/WHO), Member of the European Academy of Dermatology and Venereology (EADV), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Deputy Director for Research, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
6. Zhukova, O.V. – Doctor of Medical Sciences, Professor, Executive Director of the National Alliance of Dermatovenereologists and Cosmetologists, Member of the European Union against STIs (IUSTI/WHO), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Chief Freelance Specialist in Dermatovenereology and Cosmetology of the Central Federal District of the Russian Ministry of Health, Chief Physician, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department, Head of the Department of Dermatovenereology and Allergology with a Course of Immunology, Medical Institute, Peoples' Friendship University of Russia.
7. Ivanova, M.A. – Doctor of Medical Sciences, Professor, Member of the National Alliance of Dermatovenereologists and Cosmetologists, Member of the European Union against STIs (IUSTI/WHO), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Chief Researcher, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
8. Kisina, V.I. – Doctor of Medical Sciences, Professor, Member of the National Alliance of Dermatovenereologists and Cosmetologists, Member of the European Union against STIs (IUSTI/WHO), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Member of the Russian Interregional Society of Evidence-Based Medicine Specialists, Member of the Interdisciplinary Association of Reproductive Medicine Specialists (MARS), Chief Researcher, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
9. Kovalyk, V.P. – Doctor of Medical Sciences, Member of the European Union against STIs (IUSTI), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Member of the National Alliance of Dermatovenereologists and Cosmetologists, Associate Professor, Professor of the Department of Dermatovenereology and Cosmetology, Academy of Postgraduate Education of the Federal Scientific and Clinical Center of Specialized Medical Care and Medical Technologies of the Federal Medical-Biological Agency of Russia.
10. Titov, I.S. – Member of the National Alliance of Dermatovenereologists and Cosmetologists, Junior Researcher, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
11. Frigo, N.V. – Doctor of Medical Sciences, Member of the National Alliance of Dermatovenereologists and Cosmetologists, Member of the Association of Laboratory Service Specialists and Organizations "Federation of Laboratory Medicine", Member of the European Union against STIs (IUSTI/WHO), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Head of the Department of Scientific and Applied Research Methods, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
12. Chernova, N.I. – Doctor of Medical Sciences, Professor, Member of the National Alliance of Dermatovenereologists and Cosmetologists, Member of the European Union against STIs (IUSTI/WHO), Member of the Guild of Specialists in Sexually Transmitted Infections "JUSTI RU", Vice President of the Russian Association for Genital Infections and Neoplasia (RAGIN), Member of the International Society for the Study of Vulvovaginal Disorders (ISSVD), Member of the Russian Society of Obstetricians and Gynecologists (ROAG), Member of the Interdisciplinary Association of Reproductive Medicine Specialists (MARS), Member of the European Association of Urology (EAU), Head of the Department of Anogenital Dermatoses and Sexually Transmitted Infections, Moscow Scientific and Practical Center of Dermatovenereology and Cosmetology of the Moscow Healthcare Department.
Conflict of interest: None declared.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
1. Dermatovenereologists;
2. Coloproctologists;
3. Urologists;
4. Infectious disease specialists;
5. Otorhinolaryngologists;
6. Obstetrician-gynecologists.
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. Levels of Evidence (LE) rating scale for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definitions |
|---|---|
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 grading grades of recommendation (GoR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, rehabilitation 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
1. Order of the Ministry of Health of the Russian Federation No. 1130n dated October 20, 2020, "On Approval of the Procedure for Providing Medical Care in the Field of 'Obstetrics and Gynecology'".
2. Order of the Ministry of Health of the Russian Federation No. 924n dated November 15, 2012, "On Approval of the Procedure for Providing Medical Care to the Population in the Field of 'Dermatovenereology'".
3. Order of the Ministry of Health of the Russian Federation No. 907n dated November 12, 2012, "On Approval of the Procedure for Providing Medical Care to the Adult Population in the Field of 'Urology'".
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Key facts:
Lymphogranuloma venereum is sexually transmitted, including through oral and anal sex. Symptoms typically develop when the pathogen is localized in the rectum, resulting from anal-genital sexual contact with an infected partner. If left untreated, this infection can cause serious health problems.
You can protect yourself by consistently using condoms during sexual intercourse.
What is chlamydial lymphogranuloma venereum?
Lymphogranuloma venereum is a sexually transmitted infection caused by the bacterium Chlamydia trachomatis (L1-L3).
How can you contract lymphogranuloma venereum?
You can get infected if your partner has this infection. Transmission can occur via oral, vaginal, or anal sex. This infection is most common among men who have sex with men, particularly those with multiple sexual partners who do not use condoms during sex. Even if you have had LGV in the past, you can be infected again.
What are the symptoms of LGV?
The primary stage of the disease (a papule at the site of pathogen entry) usually goes unnoticed.
The most common symptoms in men:
- pain in the anus and rectum,
- tenderness upon palpation of regional lymph nodes,
- bloody or purulent anal discharge,
- fever.
The most common symptoms in women:
- tenderness upon palpation of regional lymph nodes,
- pain in the anus and rectum,
- fever.
Should I get tested?
Yes, a genital and rectal swab is necessary for diagnosis. A urine test is also performed in some cases. If you have had sexual contact with a patient diagnosed with chlamydia or other infections, or if you have symptoms suggestive of LGV infection, you should consult a dermatovenereologist. The doctor will take a swab from the urethra, vagina, or cervix and send it to the laboratory for Chlamydia trachomatis (L1-L3) testing. If you have engaged in oral or anal sex, you should inform your doctor so that throat and anal swabs can be taken. In some cases, you may collect a sample yourself.
If you have chlamydia, you should be screened for other sexually transmitted infections, such as HIV, syphilis, hepatitis B and C, and gonorrhea.
How is LGV treated?
It is crucial to initiate treatment as early as possible, as this infection can cause complications and serious health problems. LGV is treated with systemic antibacterial medications in tablet form.
Can I have sex if I have LGV?
You must abstain from all types of sexual contact, even with a condom, until you and your partner have completed treatment and all symptoms have resolved.
What are the possible complications?
Serious complications include damage to lymphatic vessels and lymph nodes (formation of adhesions in the lymphatic system), which leads to impaired lymph drainage in the genital and rectal areas. Untreated LGV with localization of the pathogen in the rectal region typically leads to severe forms of proctitis—erosive-ulcerative and necrotic proctitis accompanied by septic phenomena. Long-term complications of such proctitis may include rectal fistulas and strictures of the rectum up to the point of obstruction.
Should I tell my partner?
If you have LGV, you must inform your sexual partner and any other partners you have had over the past two months as soon as possible. They need to be tested and treated. This will protect you from reinfection and prevent potential complications in your partners.
Further Care and Information
If you suspect you have LGV or another sexually transmitted infection, you should consult a dermatovenereologist.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
No.