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Trials. 2017 Nov 13;18(1):534. doi: 10.1186/s13063-017-2211-1.

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

Author information

1
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.
2
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.
3
Service de Gynécologie Obstétrique, Centre Hospitalier Régional Universitaire de Nancy, 10 rue du Dr Heydenreich, 54000, Nancy, France.
4
Research Unit EA 7285, Risk and safety in clinical medicine for women and perinatal health, Versailles-Saint-Quentin University (UVSQ), Montigny-le-Bretonneux, France.
5
Department of Gynaecology and Obstetrics, Intercommunal Hospital Centre of Poissy-Saint-Germain-en-Laye, Poissy, France.
6
Santé Publique France, 12 Rue du Val d'Osne, 94410, Saint-Maurice, France.
7
Department of Clinical Research, URC HUPIFO, Hôpital Ambroise Paré, Assistance Publique - Hôpitaux de Paris (AP-HP), 9 avenue Charles de Gaulle, 92100, Boulogne-Billancourt, France.
8
Institute for Genome Sciences, University of Maryland School of Medicine, 801 West Baltimore Street, Baltimore, MD, 21201, USA.
9
Department of Microbiology and Immunology, University of Maryland School of Medicine, 801 West Baltimore Street, Baltimore, MD, 21201, USA.
10
Laboratory of Immunogenetics, Department of Medical Microbiology and Infection Control, Research School V-ICI, VU University Medical Centre, De Boelelaan 1118, 1081HV, Amsterdam, The Netherlands.
11
Institute for Public Health Genomics, Department of Genetics and Cell Biology, Research Institute GROW (School for Oncology and Developmental Biology), Faculty of Health, Medicine and Life Sciences, University of Maastricht (UM), Universiteitssingel 50, 6229 ER, Maastricht, The Netherlands.
12
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. elisabeth.delarocque-astagne@pasteur.fr.

Abstract

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.

KEYWORDS:

Chlamydia trachomatis; Clearance; Immunogenetics; Infection; Natural course of infection; Pelvic inflammatory disease; Prevention; Reinfection; Screening; Students

PMID:
29132441
PMCID:
PMC5683219
DOI:
10.1186/s13063-017-2211-1
[Indexed for MEDLINE]
Free PMC Article

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