Tamarelle Jeanne, Thiébaut Anne C M, Sabin Bénédicte, Bébéar Cécile, Judlin Philippe, Fauconnier Arnaud, Rahib Delphine, Méaude-Roufai Layidé, Ravel Jacques, Morré Servaas A, de Barbeyrac Bertille, Delarocque-Astagneau Elisabeth
Biostatistics, Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PhI), Inserm, UVSQ, Institut Pasteur, Université Paris-Saclay, 2 avenue de la source de la Bièvre, 78180, Montigny-le-Bretonneux, France.
French National Reference Centre for Chlamydia, USC EA 3671, Mycoplasmal and Chlamydial Infections in Humans, University of Bordeaux, Campus Bordeaux Carreire, 146 rue Léo Saignat, 33076, Bordeaux cedex, France.
Trials. 2017 Nov 13;18(1):534. doi: 10.1186/s13063-017-2211-1.
Genital infection with Chlamydia trachomatis (Ct) is the most common bacterial sexually transmitted infection, especially among young women. Mostly asymptomatic, it can lead, if untreated, to pelvic inflammatory disease (PID), tubal factor infertility and ectopic pregnancy. Recent data suggest that Ct infections are not controlled in France and in Europe. The effectiveness of a systematic strategy for Ct screening in under-25 women remains controversial. The main objective of the i-Predict trial (Prevention of Diseases Induced by Chlamydia trachomatis) is to determine whether early screening and treatment of 18- to-24-year-old women for genital Ct infection reduces the incidence of PID over 24 months.
METHODS/DESIGN: This is a randomised prevention trial including 4000 eighteen- to twenty-four-year-old sexually active female students enrolled at five universities. The participants will provide a self-collected vaginal swab sample and fill in an electronic questionnaire at baseline and at 6, 12 and 18 months after recruitment. Vaginal swabs in the intervention arm will be analysed immediately for Ct positivity, and participants will be referred for treatment if they have a positive test result. Vaginal swabs from the control arm will be analysed at the end of the study. All visits to general practitioners, gynaecologists or gynaecology emergency departments for pelvic pain or other gynaecological symptoms will be recorded to evaluate the incidence of PID, and all participants will attend a final visit in a hospital gynaecology department. The primary endpoint measure will be the incidence of PID over 24 months. The outcome status (confirmed, probable or no PID) will be assessed by two independent experts blinded to group assignment and Ct status.
This trial is expected to largely contribute to the development of recommendations for Ct screening in young women in France to prevent PID and related complications. It is part of a comprehensive approach to gathering data to facilitate decision-making regarding optimal strategies for Ct infection control. The control group of this randomised trial, following current recommendations, will allow better documentation of the natural history of Ct infection, a prerequisite to evaluating the impact of Ct screening. Characterisation of host immunogenetics will also allow identification of women at risk for complications.
ClinicalTrials.gov, NCT02904811 . Registered on September 14, 2016. World Health Organisation International Clinical Trials Registry, NCT02904811. AOM, 15-0063 and P150950. Registered on September 26, 2016. A completed Standard Protocol Items : Recommendations for International Trials (SPIRIT) Checklist is available in additional file 1.
沙眼衣原体（Ct）生殖器感染是最常见的细菌性性传播感染，在年轻女性中尤为常见。该病大多无症状，若不治疗，可导致盆腔炎（PID）、输卵管因素不孕和异位妊娠。最新数据表明，法国和欧洲的Ct感染未得到有效控制。针对25岁以下女性进行Ct筛查的系统策略的有效性仍存在争议。i-Predict试验（预防沙眼衣原体所致疾病）的主要目标是确定对18至24岁女性进行生殖器Ct感染的早期筛查和治疗是否能在24个月内降低PID的发病率。
方法/设计：这是一项随机预防试验，纳入了五所大学的4000名18至24岁有性行为的女学生。参与者将在基线时以及招募后6个月、12个月和18个月提供自行采集的阴道拭子样本，并填写电子问卷。干预组的阴道拭子将立即进行Ct阳性检测，检测结果呈阳性的参与者将被转诊接受治疗。对照组的阴道拭子将在研究结束时进行分析。记录所有因盆腔疼痛或其他妇科症状前往全科医生、妇科医生或妇科急诊科就诊的情况，以评估PID的发病率，所有参与者将在医院妇科进行最后一次就诊。主要终点指标将是24个月内PID的发病率。结局状态（确诊、可能或无PID）将由两名对分组和Ct状态不知情的独立专家进行评估。
该试验有望在很大程度上为法国制定针对年轻女性的Ct筛查建议以预防PID及相关并发症做出贡献。它是收集数据以促进关于Ct感染控制最佳策略决策的综合方法的一部分。该随机试验的对照组按照当前建议，将有助于更好地记录Ct感染的自然史，这是评估Ct筛查影响的前提条件。宿主免疫遗传学特征分析也将有助于识别有并发症风险的女性。
ClinicalTrials.gov，NCT02904811。于2016年9月14日注册。世界卫生组织国际临床试验注册平台，NCT02904811。AOM，15 - 0063和P150950。于2016年9月26日注册。完整的标准协议项目：国际试验推荐（SPIRIT）清单见附加文件1。
