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NCT05872438 Clinical Trial

Evaluation of Multisite Sampling to Detect C. Trachomatis or N. Gonorrheae Compared With Vaginal Sampling in Women at Risk for Sexually Transmitted Infections

Sexually Transmitted Infection Clinical Trial

— SIST'RS  

Official title:
Evaluation of Multisite Sampling to Detect C. Trachomatis or N. Gonorrheae Compared With Vaginal Sampling in Women at Risk for Sexually Transmitted Infections (STI)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05872438
Other study ID # CHRO-2022-16
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 14, 2023
Est. completion date April 2024

Study information
Verified date July 2023
Source Centre Hospitalier Régional d'Orléans
Contact Thierry PRAZUCK, Dr
Phone 02 38 22 95 93
Email thierry.prazuck@chr-orleans.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Screening for STIs in MSM is based on multisite samples: urine, anal and oral for PCR targeting C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis, whereas only vaginal self-sampling is recommended in women. Recent publications and observations suggest that a substantial number of STIs are under diagnosed with the current recommendations. The main objective of the study is to assess the number and percentage of additional C. trachomatis and N. gonorrhoeae infections diagnosed by a multiple sampling strategy in women, particularly when the vaginal sampling is negative The secondary objective will assess the acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women.

Description:

1500 women will be included in 5 different screening STIs centers in France based of the prevalence of STIs in this population (10% C. trachomatis) and the hypothesis that this new strategy allows to detect 20% more underdiagnosed STIs The sequential recruitment will concern women attending at one of the 5 STIs screening centers, whether they are symptomatic or not. If they agree to participate in the study, the patients will take the samples themselves from the 3 sites (vaginal, anal and oral self-sampling) using standard swabs (brand). The sample will immediately be placed in the transport medium in each of the 3 Sigma VCM tubes labeled by the patient, depending on the collection site. The study nurse will register the inclusion of patients, identify the tubes, collect information and send them to the local laboratory for the PCR to be performed. The study will be continued until the number of patients to be included for each of the centers is obtained. The anonymized data will be entered on an Excel database. The results of the PCRs will be collected a posteriori by the IDEs to populate the database. The PCR result will be given both qualitatively (positive/negative) and CT value for C. trachomatis and N. gonorrhoeae infections.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women coming for STI screening at a Cegidd - Asymptomatic or not - Women aged at least 18 years - Having given her consent to participate Exclusion Criteria: - Patient having received antibiotic treatment covering C.trachomatis and N.gonorrheae in the month preceding the screening - Patient under guardianship or curatorship - Patient under legal protection - Pregnant or breastfeeding woman

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Vaginal, Oral and anal sampling
The patients will take the samples themselves from the 3 sites (vaginal, anal and oral self-sampling) using standard swabs (brand). The sample will immediately be placed in the transport medium in each of the 3 Sigma VCM tubes labeled by the patient, depending on the collection site. The study nurse will register the inclusion of patients, identify the tubes, collect information and send them to the local laboratory for the PCR to be performed.

Locations
Country Name City State
France CeGIDD Orléans
France CHRU de POITIERS Poitiers
France CH de Saint Nazaire Saint-Nazaire
France CHU de STRASBOURG Strasbourg
France CHU de Tours Tours

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (5)

Alexander S, Ison C, Parry J, Llewellyn C, Wayal S, Richardson D, Phillips A, Smith H, Fisher M; Brighton Home Sampling Kits Steering Group. Self-taken pharyngeal and rectal swabs are appropriate for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in asymptomatic men who have sex with men. Sex Transm Infect. 2008 Nov;84(6):488-92. doi: 10.1136/sti.2008.031443. — View Citation

Lunny C, Taylor D, Hoang L, Wong T, Gilbert M, Lester R, Krajden M, Ogilvie G. Self-Collected versus Clinician-Collected Sampling for Chlamydia and Gonorrhea Screening: A Systemic Review and Meta-Analysis. PLoS One. 2015 Jul 13;10(7):e0132776. doi: 10.1371/journal.pone.0132776. eCollection 2015. — View Citation

Prazuck T, Lanotte P, Le Moal G, Hocqueloux L, Sunder S, Catroux M, Garcia M, Perfezou P, Gras G, Plouzeau C, Leveque N, Beby-Defaux A. Pooling Rectal, Pharyngeal, and Urine Samples to Detect Neisseria gonorrhoeae, Chlamydia trachomatis, and Mycoplasma genitalium Using Multiplex Polymerase Chain Reaction Is as Effective as Single-Site Testing for Men Who Have Sex With Men. Open Forum Infect Dis. 2022 Oct 31;9(10):ofac496. doi: 10.1093/ofid/ofac496. eCollection 2022 Oct. — View Citation

Verougstraete N, Verbeke V, De Canniere AS, Simons C, Padalko E, Coorevits L. To pool or not to pool? Screening of Chlamydia trachomatis and Neisseria gonorrhoeae in female sex workers: pooled versus single-site testing. Sex Transm Infect. 2020 Sep;96(6):417-421. doi: 10.1136/sextrans-2019-054357. Epub 2020 May 13. — View Citation

Wayal S, Llewellyn C, Smith H, Hankins M, Phillips A, Richardson D, Fisher M; Home Sampling Kit Project Steering Group. Self-sampling for oropharyngeal and rectal specimens to screen for sexually transmitted infections: acceptability among men who have sex with men. Sex Transm Infect. 2009 Feb;85(1):60-4. doi: 10.1136/sti.2008.032193. Epub 2008 Aug 15. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Detectability of STIs in women on multisite samples Number and percentage percentage of additional STI diagnosed with the 3 sites sampling compared to the vaginal sampling alone Baseline
Secondary Percentage of women accepting anal and oropharyngeal self-sampling acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women Baseline
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