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| ID | Type | Description | Link |
|---|---|---|---|
| AOM 15-0063 | Other Identifier | AP-HP |
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| Name | Class |
|---|---|
| National Reference Center (NRC) for Chlamydia infections, UMR1181 | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | Experimental | Testing for Ct infection at the end of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing for Ct infection immediately | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence | Cumulative incidence of first PID | At 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of first Ct infection | Incidence of first Ct infection for negative participants at baseline | Up to 24 months |
| Duration of Ct infection | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Delarocque-Astagneau, MD | Université de Versailles Saint Quentin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Versailles Saint Quentin | Versailles | Saint-Quentin-en-Yvelines | 78000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39302529 | Derived | Tamarelle J, Thiebaut ACM, de Barbeyrac B, Bebear C, Bourret A, Fauconnier A, Ravel J, Delarocque-Astagneau E; i-Predict study group. Vaginal microbiota stability over 18 months in young student women in France. Eur J Clin Microbiol Infect Dis. 2024 Dec;43(12):2277-2292. doi: 10.1007/s10096-024-04943-3. Epub 2024 Sep 20. | |
| 29132441 |
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| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D034161 | Pelvic Infection |
| D007239 | Infections |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| Testing for Ct infection at the end of the study | Other | Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18). |
|
| Proportion of Ct infection progressing to PID | Up to 24 months |
| Time of Ct infection progressing to PID | Up to 24 months |
| Proportion of spontaneous resolution of Ct infections | Proportion of spontaneous resolution of Ct infections | Up to 24 months |
| Incidence of reinfections | Incidence of reinfections | Up to 24 months |
| Tamarelle J, Thiebaut ACM, Sabin B, Bebear C, Judlin P, Fauconnier A, Rahib D, Meaude-Roufai L, Ravel J, Morre 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |