Sexually Transmitted InfectionSIST'RSNCT05872438
Evaluation of Multisite Sampling to Detect C. Trachomatis or N. Gonorrheae Compared With Vaginal Sampling in Women at Risk for Sexually Transmitted Infections
A study testing Vaginal, Oral and anal sampling in people with Sexually Transmitted Infection, run by Centre Hospitalier Régional d'Orléans at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexually Transmitted Infection
- What is being tested?
- Vaginal, Oral and anal sampling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 7 sitesFrance
- Study dates
- 14 Apr 2023to 19 Sep 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women coming for STI screening at a Cegidd
- Asymptomatic or not
- Women aged at least 18 years
- Having given her consent to participate
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CeGIDD
Orléans, 45000
CHRU de POITIERS
Poitiers, 86021
Centre Hospitalier de Cornouaille
Quimper
CH de Saint Nazaire
Saint-Nazaire
CHU de STRASBOURG
Strasbourg, 67000
CHU de Tours
Tours, 37044
Centre Hospitalier de Vierzon
Vierzon
About this study
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)
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.
Read the detailed 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.
- Conditions
- Sexually Transmitted Infection
- Being tested
- Vaginal, Oral and anal sampling
- Keywords
- Sexually Transmitted Infection, PCR, C. trachomatis, N. gonorrhoeae, Screening
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal, Oral and anal samplingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Multisite sampling | Other | Vaginal, Oral and anal sampling for all participants Receives: Diagnostic Test: Vaginal, Oral and anal sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (1)
Percentage of women accepting anal and oropharyngeal self-sampling
acceptability of anal and oropharyngeal self-sampling relative to vaginal self-sampling in women
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start14 Apr 2023
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted InfectionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Comparison of screening for two hypothesis: How many and what percentage of additional STI are diagnosed with the 3 sites sampling compared to the vaginal sampling alone?
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julienne EFFA, Dr, Principal investigator, CHU d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872438
- Sponsor's protocol ID
- CHRO-2022-16
- Acronym
- SIST'RS
- Status last verified
- Nov 2024
- First submitted
- 3 May 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36324326Verougstraete 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.
PubMed 32404400Lunny 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.
PubMed 26168051Alexander 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.
PubMed 19028953Wayal 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.
PubMed 18708480
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05872438
- Acronym / sponsor ID
- SIST'RS / CHRO-2022-16
- Conditions
- Sexually Transmitted Infection
- Keywords
- Sexually Transmitted Infection, PCR, C. trachomatis, N. gonorrhoeae, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 24 May 2023 (actual)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Comparison of screening for two hypothesis: How many and what percentage of additional STI are diagnosed with the 3 sites sampling compared to the vaginal sampling alone?
| Arm | Type | Receives |
|---|---|---|
| Multisite sampling | Other | Diagnostic Test: Vaginal, Oral and anal samplingVaginal, Oral and anal sampling for all participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women coming for STI screening at a Cegidd
- Asymptomatic or not
- Women aged at least 18 years
- Having given her consent to participate
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Vaginal, Oral and anal samplingThe 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. | Diagnostic test | Multisite sampling |
Primary outcome
Detectability of STIs in women on multisite samples
Time frame: Baseline
Number and percentage percentage of additional STI diagnosed with the 3 sites sampling compared to the vaginal sampling alone
1 secondary outcome
Percentage of women accepting anal and oropharyngeal self-sampling
Time frame: Baseline
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 18 Nov 2024.
- Background: PubMed 36324326Prazuck 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.
- Background: PubMed 32404400Verougstraete 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.
- Background: PubMed 26168051Lunny 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.
- Background: PubMed 19028953Alexander 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.
- Background: PubMed 18708480Wayal 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.
- World Health Organization. Sexually transmitted infectionsLink provided by the sponsor.
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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.
Julienne EFFA, Dr principal investigator
CHU d'Orléans
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal, Oral and anal sampling in people with Sexually Transmitted Infection, run by Centre Hospitalier Régional d'Orléans at 7 sites 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 4 inclusion and 4 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Detectability of STIs in women on multisite samples (time frame: Baseline). 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 NCT05872438, which also lists 5 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 18 Nov 2024.