Lymphogranuloma venereum (LGV) is a sexually transmitted infection (STI) caused by the L genotypes of C. trachomatis. Proctitis is the main clinical manifestation of infection in the current LGV epidemic. However, recent European studies reported that about 25% of the anal LGV infections are asymptomatic. In France, asymptomatic anal LGV increased from 36.1% (44/124) in 2020 to 52.4% (66/126) in 2022. LGV testing is recommended on all C. trachomatis-positive anorectal specimens because therapy of extended duration is required. Patients with anal C. trachomatis infection should be treated initially with 7-day course of doxycycline (200 mg per day orally) while awaiting the results of LGV testing. Treatment should be extended to 21 days in cases of LGV according to current European and USA guidelines for LGV treatment. This regimen is indicated for symptomatic and asymptomatic anorectal LGV, with a 98.5% treatment efficacy. However, there is no obvious biological basis for prolonged treatment of asymptomatic LGV. Three recent retrospective studies showed that a 7-day course of doxycycline was effective for the treatment of asymptomatic LGV, with microbial cure ranging from 97% (38/39) to 100% (54/54). The objective of this study is to evaluate the efficacy (microbiological cure rate) of a 7-day course of doxycycline 200 mg daily orally for the treatment of asymptomatic anal LGV infection, four weeks after treatment initiation.
Lymphogranuloma venereum (LGV) is a sexually transmitted infection (STI) caused by the L genotypes of C. trachomatis. LGV have reemerged in Europe, primarily in men who have sex with men (MSM). The number of LGV cases reported has risen year on year, from 739 in 2011 to 3124 in 2019 in European countries. Proctitis is the main clinical manifestation of infection in the current LGV epidemic. Recent European studies reported that about 25% of the anal LGV infections are asymptomatic. In France, asymptomatic anal LGV increased from 36.1% (44/124) in 2020 to 52.4% (66/126) in 2022. Guidelines on the management of LGV recommended that all MSM with anorectal C. trachomatis-positive specimens should be tested for LGV irrespective of symptoms. However, access to routine LGV testing is inconsistent in France and other European countries, and specimens need to be referred to expert laboratories with substantial additional cost and significant delay to receiving results. LGV testing is recommended because therapy of extended duration is required. Patients with anal C. trachomatis infection should be treated initially with 7-day course of doxycycline (200 mg per day orally) while awaiting the results of LGV testing. Treatment should be extended to 21 days in cases of LGV according to current European and USA guidelines for LGV treatment. This regimen is indicated for symptomatic and asymptomatic anorectal LGV, with a 98.5% treatment efficacy. However, there is no obvious biological basis for prolonged treatment of asymptomatic LGV. Three recent retrospective studies showed that a 7-day course of doxycycline was effective for the treatment of asymptomatic LGV, with microbial cure ranging from 97% (38/39) to 100% (54/54). These results suggest that a shorter course of doxycycline could be sufficient for treating asymptomatic anal LGV. In this study, subjects without anorectal symptoms and with anal specimens positive for LGV will be treated by a 7-day course of doxycycline 200 mg daily orally. The microbiological cure will be estimated four weeks after treatment initiation, with a self-collected anal specimen for the detection of LGV
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Doxycycline 200 mg daily orally for seven days
University Hospital, Bordeaux, Department of Infectious Diseases
Bordeaux, France
Hopital François Mitterrand, Centres Gratuits D'Information, de Depistage Et de Diagnostic (Ceggid)
Dijon, France
Hospices Civils de Lyon, Centres Gratuits D'Information, de Depistage Et de Diagnostic (Ceggid)
Lyon, France
Service de Prevention Aupres Des Jeunes, Ceggid
Marseille, France
Hopital Intercommunal Andre Gregoire - Ght , Centres Gratuits D'Information, de Depistage Et de Diagnostic (Ceggid)
Montreuil, France
Chu de Nantes, Maladies Infectieuses (Cpmit)
Nantes, France
Hotel-Dieu, Service Des Maladies Infectieuses Et Tropicales
Paris, France
Hopital La Pite Salpetriere, Service Des Maladies Infectieuses Et Tropicales
Paris, France
Hopital Bichat - Claude Bernard, Ceggid
Paris, France
Hopital Bichat - Claude Bernard, Service Des Maladies Infectieuses Et Tropicales
Paris, France
...and 4 more locations
Microbiological cure rate of a 7-day course of doxycycline for asymptomatic anal LGV
The microbiological cure is defined as a LGV-negative NAAT (Nucleic Acid Amplification Test) result in anal specimens four weeks after treatment initiation, among participants with a LGV-positive NAAT result at baseline.
Time frame: 4 weeks after treatment initiation
Differentiation of reinfection from treatment failure at Week 4
Genotyping (ompA gene) of C. trachomatis-positive specimens obtained at week 4 to differentiate reinfection (different ompA-genotype, or unprotected anal intercourse with an untreated/new partner) from treatment failure (identical ompA-genotype, or no anal intercourse/consistent condom use since inclusion).
Time frame: 4 weeks after treatment initiation
Chlamydia trachomatis bacterial load in anal specimens
C. trachomatis load will be measured at baseline and four weeks after treatment initiation using quantitative real-time PCR, reported as the number of DNA copies per microliter.
Time frame: Baseline and 4 weeks after treatment initiation
Molecular mechanisms of doxycycline resistance
Identification of molecular mechanisms for doxycycline resistance by amplification and sequencing of target genes (including 16S rRNA gene) in all LGV-positive specimens collected at baseline and four weeks after treatment initiation.
Time frame: Baseline and 4 weeks after treatment initiation
Adherence to doxycycline treatment
Adherence to the 7-day doxycycline regimen will be evaluated using a patient self-completed daily diary, along with pill count and return of treatment packaging at the inclusion and follow-up visits.
Time frame: From treatment initiation to 4 weeks after treatment initiation
Incidence of adverse events and serious adverse events
Number and percentage of participants experiencing adverse events (AEs) and serious adverse events (SAEs) related or unrelated to doxycycline, recorded in the e-CRF
Time frame: up to 6 weeks
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