Multicentre Study Evaluating the Efficacy of a 7-day Course of Doxycycline for the Treatment of Asymptomatic Anal Lymphogranuloma Venereum.
Condition(s) studied
Investigational drug(s) / intervention(s)
Doxycline: Doxycycline 200 mg daily orally for seven days
Study summary
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.
Eligibility
Primary outcome measure(s)
- Microbiological cure rate of a 7-day course of doxycycline for asymptomatic anal LGV — 4 weeks after treatment initiation
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.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| Hopital Saint-Louis, Service Des Maladies Infectieuses Et Tropicales | Paris | France | |
| Chu Toulouse Purpan, Service Des Maladies Infectieuses Et Tropicales | Toulouse | France | |
| Centre Hospitalier de Tourcoing, Ceggid | Tourcoing | France | |
| Centre Hospitalier de Tourcoing, Service Des Maladies Infectieuses Et Tropicales | Tourcoing | France |
More University Hospital, Bordeaux trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07767422 on ClinicalTrials.gov ↗ ← All trials in France