Ireland
--:--IST
Starting soon Phase 2

Multicentre Study Evaluating the Efficacy of a 7-day Course of Doxycycline for the Treatment of Asymptomatic Anal Lymphogranuloma Venereum.

NCT07767422 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2026-09
Last updated
2026-08-17

Condition(s) studied

Lymphogranuloma Venereumno Anorectal SymptomsDoxycycline

Investigational drug(s) / intervention(s)

Doxycline

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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Male sex at birth * LGV-positive result on anal specimen using Nucleic Acid Amplification Test at screening * Having taken at least doxycycline for two days (i.e 400 mg of doxycycline) * Not having taken more than 7 days of doxycycline 200 mg per day * No more than 12 days between the date of sampling and date of inclusion * No anorectal symptoms * Individual available for participation and follow-up during the four weeks required for the study * Affiliate or beneficiary of a social security scheme * Free written informed consent signed by the participant or by a legal representative (in the event of the participant's inability to consent) and the investigator (no later than the day of inclusion and before any examination required by the research). Exclusion Criteria: * Individual with anorectal symptoms * Antibiotic treatment with antichlamydial activity (fluoroquinolones, macrolides-lincosamides-streptogramins, tetracyclines and rifampicin) within 28 days before the screening visit * Use of doxycycline post-exposure prophylaxis (Doxy-PEP) * Participation in another study * Individual under a measure of legal protection measure (safeguard of justice, guardianship or curatorship) or unable to consent * Refusal to participate in the study * Mental state rendering the person giving consent incapable of understanding the entirety of the trial * Participant detained by judicial or administrative decision. * Individual receiving an anticoagulant therapy * Individual with a history of known hypersensitivity to doxycycline or any other antibiotic of the tetracycline family or allergy to any of the excipients (Hydrogenated castor oil, povidone, anhydrous colloidal silica, magnesium stearate, microcrystalline cellulose, sodium carboxymethyl starch (type A)). * Individual treated with retinoids by general route. * Individual receiving 10,000 IU of vitamin A per day or more * Individual being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators

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)

FacilityCityRegionStatus
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
Official registry record

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