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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Doxycline

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators