2025-524978-42-00招募中2 期
Multicentre study evaluating the efficacy of a 7-day course of doxycycline for the treatment of asymptomatic anal lymphogranuloma venereum SHORT-LGV
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 12
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •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).
- •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 screening 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
排除标准
- •Individual with proctitis
- •Antibiotic treatment with antichlamydial activity (fluoroquinolones, macrolides–lincosamides–streptogramins–ketolides, tetracyclines and rifampicin) within 28 days at the screening visit
- •Use of doxycycline post-exposure prophylaxis (Doxy-PEP)
- •Participation in another study evaluating an antibiotic for STIs or other types of infection
- •Individual under a measure of legal protection measure (safeguard of justice, guardianship or curatorship) or unable to consent
- •Refusal to participate in the study
- •Objectives of the study not understood
- •Participant detained by judicial or administrative decision
研究组 & 干预措施
DOXYCYCLINE SANDOZ 100 mg, comprimé sécable
Test
干预措施: DOXYCYCLINE SANDOZ 100 mg, comprimé sécable (Drug)
研究者
Principal Investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (12)
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