Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial

Autor: Jeanne, Tamarelle, Anne C M, Thiébaut, Bénédicte, Sabin, Cécile, Bébéar, Philippe, Judlin, Arnaud, Fauconnier, Delphine, Rahib, Layidé, Méaude-Roufai, Jacques, Ravel, Servaas A, Morré, Bertille, de Barbeyrac, Elisabeth, Delarocque-Astagneau, Nathalie, Lydié
Přispěvatelé: BMC, BMC, Biostatistique, Biomathématique, Pharmacoépidémiologie et Maladies Infectieuses (B2PHI), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), USC EA 3671 Mycoplasmal and chlamydial infections in humans, Université de Bordeaux (UB), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Service de gynécologie et obstétrique [CHI Poissy-Saint Germain], CHI Poissy-Saint-Germain, Santé publique France - French National Public Health Agency [Saint-Maurice, France], Hôpital Ambroise Paré [AP-HP], University of Maryland [Baltimore County] (UMBC), University of Maryland System, VU University Medical Center [Amsterdam], School for Oncology and Developmental Biology [Maastricht] (GROW), Maastricht University [Maastricht]-Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], The i-Predict trial was funded by the Programme Hospitalier de Recherche Clinique National (PHRC-N) 2015 (reference number PHRC-15-0063). Preliminary work for this trial was financed by 2013 Institut National du Cancer- Institut de Recherche en Santé Publique (INCa-IReSP) call for projects 'Recherche Prévention Primaire' (reference number A15012LS)., RS: GROW - R4 - Reproductive and Perinatal Medicine, Institute for Public Health Genomics, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM)
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Time Factors
Adolescent
[SDV]Life Sciences [q-bio]
GENITAL-INFECTION
FRANCE
Chlamydia trachomatis
SUSCEPTIBILITY
Young Adult
Study Protocol
Sex Factors
Clinical Protocols
Predictive Value of Tests
Risk Factors
chlamydia trachomatis
clearance
immunogenetics
infection
natural course of infection
pelvic inflammatory disease
prevention
reinfection
screening
students
Prevalence
Immunogenetics
Humans
Single-Blind Method
Students
Vaginal Smears
RISK
Bacteriological Techniques
lcsh:R5-920
Incidence
Prevention
Age Factors
Chlamydia Infections
Anti-Bacterial Agents
Primary Prevention
[SDV] Life Sciences [q-bio]
Early Diagnosis
Treatment Outcome
Natural course of infection
Research Design
Reinfection
Screening
Clearance
Female
NEISSERIA-GONORRHOEAE
Infection
lcsh:Medicine (General)
Pelvic inflammatory disease
Zdroj: Trials, Vol 18, Iss 1, Pp 1-11 (2017)
Trials
Trials, 2017, 18 (1), pp.534. ⟨10.1186/s13063-017-2211-1⟩
Trials 1 (18), 1-11. (2017)
Trials, 18:534. BioMed Central Ltd
Trials, BioMed Central, 2017, 18 (1), pp.534. ⟨10.1186/s13063-017-2211-1⟩
ISSN: 1745-6215
Popis: Background 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. Discussion 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. Trial registration 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2211-1) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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