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Prevention of Diseases Induced by Chlamydia Trachomatis

NCT02904811 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1092

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

  • Genital Chlamydia Trachomatis Infection

Interventions

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.

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).

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Elisabeth Delarocque-Astagneau, MD · Université de Versailles Saint Quentin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2022-11-15
Completion
2022-11-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02904811 on ClinicalTrials.gov