Genital Chlamydia Trachomatis Infectioni-PREDICTNCT02904811
Prevention of Diseases Induced by Chlamydia Trachomatis
A study testing Testing for Ct infection immediately and Testing for Ct infection at the end of the study in people with Genital Chlamydia Trachomatis Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genital Chlamydia Trachomatis Infection
- What is being tested?
- Testing for Ct infection immediately and Testing for Ct infection at the end of the study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,092 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2017to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Known pregnancy.
Trial locations and contacts
1 site in 1 country.
France1 site
Université de Versailles Saint Quentin
Versailles, Saint-Quentin-en-Yvelines, 78000
About this study
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.
Read the 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.
- Conditions
- Genital Chlamydia Trachomatis Infection
- Being tested
- Testing for Ct infection immediately, Testing for Ct infection at the end of the study
- Keywords
- Chlamydia trachomatis, Pelvic inflammatory disease
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing for Ct infection immediatelyOther
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.
Testing for Ct infection at the end of the studyOther
Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Testing for Ct infection immediately |
| Control group | Experimental | Testing for Ct infection at the end of the study Receives: Other: Testing for Ct infection at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence
Cumulative incidence of first PID
Measured: At 24 months
Secondary outcomes (6)
Incidence of first Ct infection
Incidence of first Ct infection for negative participants at baseline
Measured: Up to 24 months
Duration of Ct infection
Measured: Up to 24 months
Proportion of Ct infection progressing to PID
Measured: Up to 24 months
Time of Ct infection progressing to PID
Measured: Up to 24 months
Proportion of spontaneous resolution of Ct infections
Proportion of spontaneous resolution of Ct infections
Measured: Up to 24 months
Incidence of reinfections
Incidence of reinfections
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start10 Jan 2017
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genital Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Reference Center (NRC) for Chlamydia infections, UMR1181
- Responsible party
- Sponsor
- Investigators
- Elisabeth Delarocque-Astagneau, MD, Study chair, Université de Versailles Saint Quentin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904811
- Sponsor's protocol ID
- P150950
- Other IDs
- AOM 15-0063
- Acronym
- i-PREDICT
- Status last verified
- Mar 2023
- First submitted
- 14 Sep 2016
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tamarelle J, de Barbeyrac B, Balcon C, Rutt L, France M, Bebear C, Bourret A, Fauconnier A, Ravel J, Delarocque-Astagneau E, Thiebaut ACM; i-Predict study group. Chlamydia trachomatis Incidence in Relation to Vaginal Microbiota Dynamics, Immunogenetics and Exposures in a Cohort of Young Student Women in France. J Infect Dis. 2026 Sep 23;234(3):484-495. doi: 10.1093/infdis/jiag410.
PubMed 42610699Tamarelle 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.
PubMed 39302529Tamarelle 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.
PubMed 29132441
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Diseases Induced by Chlamydia Trachomatis
- ClinicalTrials.gov ID
- NCT02904811
- Acronym / sponsor ID
- i-PREDICT / P150950
- Conditions
- Genital Chlamydia Trachomatis Infection
- Keywords
- Chlamydia trachomatis, Pelvic inflammatory disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Reference Center (NRC) for Chlamydia infections, UMR1181
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Testing for Ct infection immediatelyTesting 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 | Other: Testing for Ct infection at the end of the studyTesting for Ct infection at the end of the study |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- Known pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing for Ct infection immediatelySelf-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 | Intervention group |
| Testing for Ct infection at the end of the studySelf-taken vaginal samples will be tested for Ct infection at the end of the study (M18). | Other | Control group |
Primary outcome
Cumulative incidence
Time frame: At 24 months
Cumulative incidence of first PID
6 secondary outcomes
Incidence of first Ct infection
Time frame: Up to 24 months
Duration of Ct infection
Time frame: Up to 24 months
Proportion of Ct infection progressing to PID
Time frame: Up to 24 months
Time of Ct infection progressing to PID
Time frame: Up to 24 months
Proportion of spontaneous resolution of Ct infections
Time frame: Up to 24 months
Incidence of reinfections
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 42610699Tamarelle J, de Barbeyrac B, Balcon C, Rutt L, France M, Bebear C, Bourret A, Fauconnier A, Ravel J, Delarocque-Astagneau E, Thiebaut ACM; i-Predict study group. Chlamydia trachomatis Incidence in Relation to Vaginal Microbiota Dynamics, Immunogenetics and Exposures in a Cohort of Young Student Women in France. J Infect Dis. 2026 Sep 23;234(3):484-495. doi: 10.1093/infdis/jiag410.
- Derived from this study: PubMed 39302529Tamarelle 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.
- Derived from this study: PubMed 29132441Tamarelle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Delarocque-Astagneau, MD study chair
Université de Versailles Saint Quentin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing for Ct infection immediately and Testing for Ct infection at the end of the study in people with Genital Chlamydia Trachomatis Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence (time frame: At 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02904811, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.