NCT02904811: i-PREDICT

Prevention of Diseases Induced by Chlamydia Trachomatis

Completed NA Last updated 16 March 2023

What this trial tests

NA trial testing Testing for Ct infection immediately in Genital Chlamydia Trachomatis Infection in 1,092 participants. Completed in 15 November 2022.

Timeline

10 January 2017

Primary endpoint
15 November 2022

15 November 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,092
Start date	10 January 2017
Primary completion	15 November 2022
Estimated completion	15 November 2022
Sites	1 location across France

Drugs / interventions tested

• Testing for Ct infection immediately
• Testing for Ct infection at the end of the study

Conditions studied

• Genital Chlamydia Trachomatis Infection — all drugs for Genital Chlamydia Trachomatis Infection →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 24, female only, with Genital Chlamydia Trachomatis Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vaginal microbiota stability over 18 months in young student women in France.
   Tamarelle J, Thiébaut ACM, de Barbeyrac B, Bébéar C, et al · · 2024 · cited 6× · PMID 39302529 · DOI 10.1007/s10096-024-04943-3
2. Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial.
   Tamarelle J, Thiébaut ACM, Sabin B, Bébéar C, et al · · 2017 · cited 6× · PMID 29132441 · DOI 10.1186/s13063-017-2211-1