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

• ClinicalTrials.gov Identifier: NCT02904811
• Recruitment Status: Active, not recruiting
• First Posted: September 19, 2016
• Last Update Posted: February 11, 2021
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: National Reference Center (NRC) for Chlamydia infections, UMR1181
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Genital Chlamydia Trachomatis Infection	Other: Testing for Ct infection immediately; Other: Testing for Ct infection at the end of the study	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 2728 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Prevention of Diseases Induced by Chlamydia Trachomatis
• Actual Study Start Date: January 10, 2017
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: October 2021

Arms and Interventions

Arm	Intervention/treatment
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.	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.
Experimental: Control group; Testing for Ct infection at the end of the study	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).

Outcome Measures

Primary Outcome Measures :

1. Cumulative incidence [ Time Frame: At 24 months ]
   Cumulative incidence of first PID

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 24 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

France

Université de Versailles Saint Quentin

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

National Reference Center (NRC) for Chlamydia infections, UMR1181

Investigators

• Study Chair: Elisabeth Delarocque-Astagneau, MD; Université de Versailles Saint Quentin

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02904811
• Other Study ID Numbers: P150950; AOM 15-0063 ( Other Identifier: AP-HP )
• First Posted: September 19, 2016
• Last Update Posted: February 11, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Chlamydia trachomatis; Pelvic inflammatory disease

Additional relevant MeSH terms:

Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Infection