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.
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)
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
Single group
Doxycline
DrugDoxycycline 200 mg daily orally for seven days
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.
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).
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.
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.
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.
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