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Completed

NCT Number: NCT02904811

Prevention of Diseases Induced by Chlamydia Trachomatis

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.

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Key information

Age range

18 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Université de Versailles Saint Quentin

Versailles, Saint-Quentin-en-Yvelines, 78000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testing for Ct infection immediately

Other

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.

Testing for Ct infection at the end of the study

Other

Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18).

Primary outcomes

  1. Cumulative incidence

    Time frame: At 24 months

    Cumulative incidence of first PID

Secondary outcomes

  1. Incidence of first Ct infection

    Time frame: Up to 24 months

    Incidence of first Ct infection for negative participants at baseline

  2. Duration of Ct infection

    Time frame: Up to 24 months

  3. Proportion of Ct infection progressing to PID

    Time frame: Up to 24 months

  4. Time of Ct infection progressing to PID

    Time frame: Up to 24 months

  5. Proportion of spontaneous resolution of Ct infections

    Time frame: Up to 24 months

    Proportion of spontaneous resolution of Ct infections

  6. Incidence of reinfections

    Time frame: Up to 24 months

    Incidence of reinfections

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • National Reference Center (NRC) for Chlamydia infections, UMR1181

Registry information

Acronym: i-PREDICT

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2016
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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