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NOT YET RECRUITING
NCT07767422
PHASE2

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-09

Completion Date

2027-11

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

DRUG

Doxycline

Doxycycline 200 mg daily orally for seven days

Locations (14)

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