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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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
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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 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Information from the National Library of Medicine

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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904811


Contacts
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Contact: Elisabeth Delarocque-Astagneau, MD +33 (0)1 45 68 82 27 elisabeth.delarocque-astagne@pasteur.fr

Locations
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France
Université de Versailles Saint Quentin Recruiting
Versailles, Saint-Quentin-en-Yvelines, France, 78000
Contact: Elisabeth Delarocque-Astagneau, MD    +33 (0)1 45 68 82 27    elisabeth.delarocque-astagne@pasteur.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Reference Center (NRC) for Chlamydia infections, UMR1181
Investigators
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Study Chair: Elisabeth Delarocque-Astagneau, MD Université de Versailles Saint Quentin
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
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:
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Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
 Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female