Université de Versailles Saint Quentin
Versailles, Saint-Quentin-en-Yvelines, 78000, France
NCT Number: NCT02904811
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.
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Notify Me18 year–24 year
Female
Interventional
Not applicable
Versailles, Saint-Quentin-en-Yvelines, 78000, France
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18).
Time frame: At 24 months
Cumulative incidence of first PID
Time frame: Up to 24 months
Incidence of first Ct infection for negative participants at baseline
Time frame: Up to 24 months
Time frame: Up to 24 months
Time frame: Up to 24 months
Time frame: Up to 24 months
Proportion of spontaneous resolution of Ct infections
Time frame: Up to 24 months
Incidence of reinfections
Assistance Publique - Hôpitaux de Paris
Other
Acronym: i-PREDICT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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