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Prevention of Diseases Induced by Chlamydia Trachomatis (i-PREDICT)

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ClinicalTrials.gov Identifier: NCT02904811
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
National Reference Center (NRC) for Chlamydia infections, UMR1181
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 14, 2016
First Posted Date  ICMJE September 19, 2016
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE January 10, 2017
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
Cumulative incidence [ Time Frame: At 24 months ]
Cumulative incidence of first PID
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02904811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2016)
  • Incidence of first Ct infection [ Time Frame: Up to 24 months ]
    Incidence of first Ct infection for negative participants at baseline
  • Duration of Ct infection [ Time Frame: Up to 24 months ]
  • Proportion of Ct infection progressing to PID [ Time Frame: Up to 24 months ]
  • Time of Ct infection progressing to PID [ Time Frame: Up to 24 months ]
  • Proportion of spontaneous resolution of Ct infections [ Time Frame: Up to 24 months ]
    Proportion of spontaneous resolution of Ct infections
  • Incidence of reinfections [ Time Frame: Up to 24 months ]
    Incidence of reinfections
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Diseases Induced by Chlamydia Trachomatis
Official Title  ICMJE Prevention of Diseases Induced by Chlamydia Trachomatis
Brief Summary

The main objective of the study is to determine whether early screening and treating young women (<25 years of age) for genital Chlamydia Trachomatis (Ct) infection reduces the cumulative incidence of pelvic inflammatory disease (PID) over 24 months.

As secondary objectives, the study aims

  • To determine the baseline prevalence and the incidence of Ct infection;
  • To improve knowledge on natural history of Ct infection in young women such as the rate and timing of progression to PID (at the beginning of the infection, at the end, throughout the course of infection), as well as the incidence of reinfections with Ct;
  • To investigate the relation between host immuno-genetic factors and the clearance, persistence and development of late complications (PID) as an explanation for the inter-individual heterogeneity in the susceptibility to and course of Ct infection.
Detailed Description

In this research project, the study aims to assess a screening strategy (early screening and treatment of Ct genital infection in young women to prevent complications) that may be implemented in the future if proved efficient 7 centers are involved in the enrollment (university health services), and 4 centers will participate in the study within the frame of the follow-up and final visit (hospital gynaecology departments).

Participants included will have to perform 4 self-taken vaginal samples linked to four online corresponding questionnaires, at different timeframes 6-month apart to each other (M0, M6, M12, M18). The first sampling (M0) will be performed at the university health service, this self-taken sampling could also be performed at home later in case of menstruation; the others (M6, M12, M18) will be performed at home (or at the university if problem of sampling kits receiving at home).

Participants will be randomly assigned to one of the two following arms:

  • in the non-intervention arm, participants will follow current guidelines of Ct screening (i.e. opportunistic screening only in STI clinics for women aged less than 25 years old), and their samples will be tested for Ct at M18 by the NRC;
  • in the intervention arm, analyses for Ct will be carried out immediately by the NRC.

A final visit with a hospital gynecologist is planned for all participants between M18 and M24 and aims at providing an extensive clinical examination to seek for potential signs of pelvic inflammatory disease and to treat participants if needed.

Based on all data collected on the electronic platform through questionnaires from the different visits, independent experts blinded on chlamydia status will assess PID status of all participants (no PID, probable PID, confirmed PID).

The duration of enrollment is planned for 36 months.

The duration of follow-up for each patient is 18 months to 24 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Genital Chlamydia Trachomatis Infection
Intervention  ICMJE
  • Other: Testing for Ct infection immediately
    Self-taken vaginal samples will be immediately tested for Ct infection at the National Reference Centre (CNR) at University of Bordeaux, using a commercially available CE marketed real-time PCR assay.
  • Other: Testing for Ct infection at the end of the study
    Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18).
Study Arms  ICMJE
  • Experimental: Intervention group

    Testing for Ct infection immediately

    Participants will perform self-taken vaginal samples.

    The positive results for Ct will be examined and treated and their partner will also be informed to do so.

    Intervention: Other: Testing for Ct infection immediately
  • Experimental: Control group
    Testing for Ct infection at the end of the study
    Intervention: Other: Testing for Ct infection at the end of the study
Publications * Tamarelle J, Thiébaut ACM, Sabin B, Bébéar C, Judlin P, Fauconnier A, Rahib D, Méaude-Roufai L, Ravel J, Morré SA, de Barbeyrac B, Delarocque-Astagneau E; i-Predict study group. Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial. Trials. 2017 Nov 13;18(1):534. doi: 10.1186/s13063-017-2211-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
2728
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2016)
4000
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • female students visiting the preventive medical centers of universities or the Ct screening test centers who participate in the study;
  • participate in or will participate in the "i-Share" cohort;
  • aged between 18 to 24 years,
  • had prior sexual relations,
  • written informed consent signed,
  • affiliated to the social security bodies.

Exclusion Criteria:

  • Known pregnancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elisabeth Delarocque-Astagneau, MD +33 (0)1 45 68 82 27 elisabeth.delarocque-astagne@pasteur.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02904811
Other Study ID Numbers  ICMJE P150950
AOM 15-0063 ( Other Identifier: AP-HP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE National Reference Center (NRC) for Chlamydia infections, UMR1181
Investigators  ICMJE
Study Chair: Elisabeth Delarocque-Astagneau, MD Université de Versailles Saint Quentin
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP