Multicentre study evaluating the efficacy of a 7-day course of doxycycline for the treatment of asymptomatic anal lymphogranuloma venereum SHORT-LGV

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Bordeaux

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Decision date (initial)

2026-05-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 6

1. To evaluate the distribution of the C. trachomatis genotypes in LGV-positive anal specimens collected at baseline
2. To identify genotype for C. trachomatis-positive specimens obtained at week 4 to differentiate reinfection from treatment failure.
3. To estimate the C. trachomatis load in anal specimens collected at baseline and four weeks after treatment initiation.
4. To identify molecular mechanisms for doxycycline resistance in anal specimens collected at baseline and four weeks after treatment initiation.
5. To evaluate adherence to doxycycline.
6. To evaluate the safety (adverse events, serious adverse events).

Conditions and MedDRA coding

Asymptomatic anal LGV infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Age ≥ 18 years
2. Male sex at birth
3. LGV-positive result on anal specimen using Nucleic Acid Amplification Test at screening
4. Having taken at least doxycycline for two days (i.e 400 mg of doxycycline)
5. Not having taken more than 7 days of doxycycline 200 mg per day
6. No more than 12 days between the date of screening and date of inclusion
7. No anorectal symptoms
8. Individual available for participation and follow-up during the four weeks required for the study
9. Affiliate or beneficiary of a social security scheme
10. Free written informed consent signed by the participant or by an impartial witness (in the event of the participant’s inability to write) 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 8

1. Individual with proctitis
2. Antibiotic treatment with antichlamydial activity (fluoroquinolones, macrolides–lincosamides–streptogramins–ketolides, tetracyclines and rifampicin) within 28 days at the screening visit
3. Use of doxycycline post-exposure prophylaxis (Doxy-PEP)
4. Participation in another study evaluating an antibiotic for STIs or other types of infection
5. Individual under a measure of legal protection measure (safeguard of justice, guardianship or curatorship) or unable to consent
6. Refusal to participate in the study
7. Objectives of the study not understood
8. Participant detained by judicial or administrative decision

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The microbiological cure is defined as a LGV-negative NAAT result in anal specimen four weeks after treatment initiation among participants with a LGV-positive NAAT result at baseline.

Secondary endpoints 7

1. The distribution of the C. trachomatis genotypes in LGV-positive anal specimens collected at baseline will be studied by sequencing the ompA gene (defining the ompA-genotype) in each specimen
2. Treatment failure defined as i/identical ompA-genotype in the anal swabs collected at baseline and at four weeks after treatment initiation or ii/ the ompA genotype could not be determined, individuals reporting either no anal sexual intercourse after treatment or consistent condom use between inclusion and visit at week 4
3. Reinfection defined as i/ different ompA-genotype in the anal swabs collected at baseline and at four weeks after treatment initiation or ii/ the ompA genotype could not be determined, individuals reporting unprotected anal sexual intercourse with an untreated or a new sexual partner between inclusion and visit at week 4
4. The C. trachomatis load will be studied at baseline and four weeks after treatment initiation using a quantitative real-time PCR and will be reported as the number of DNA copies per microliter
5. Molecular mechanisms for doxycycline resistance will be studied by sequencing the target genes in all LGV-positive specimens at baseline and four weeks after treatment initiation
6. Adherence to doxycycline will be evaluated using a diary
7. Adverse events (AE) and serious adverse events (SAE) recorded in the e-CRF

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Bordeaux

Sponsor organisation

Centre Hospitalier Universitaire De Bordeaux

Address

12 Rue Dubernat, Cs 91286 Cs 91286

City

Talence

Postcode

33400

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Principal Investigator

Public contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Principal Investigator

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications