Prevention of Diseases Induced by Chlamydia Trachomatis

Genital Chlamydia Trachomatis Infection Clinical Trial

— i-PREDICT  

Official title:

Prevention of Diseases Induced by Chlamydia Trachomatis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904811
• Other study ID #: P150950
• Secondary ID: AOM 15-0063
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: November 15, 2022

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1092
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chlamydia Infections
• Genital Chlamydia Trachomatis Infection

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	Université de Versailles Saint Quentin	Versailles	Saint-Quentin-en-Yvelines

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	National Reference Center (NRC) for Chlamydia infections, UMR1181

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence	Cumulative incidence of first PID	At 24 months
Secondary	Incidence of first Ct infection	Incidence of first Ct infection for negative participants at baseline	Up to 24 months
Secondary	Duration of Ct infection		Up to 24 months
Secondary	Proportion of Ct infection progressing to PID		Up to 24 months
Secondary	Time of Ct infection progressing to PID		Up to 24 months
Secondary	Proportion of spontaneous resolution of Ct infections	Proportion of spontaneous resolution of Ct infections	Up to 24 months
Secondary	Incidence of reinfections	Incidence of reinfections	Up to 24 months