Genital InfectionNCT04039711
Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections
A study testing Vaginal self-sampling in people with Genital Infection and Asymptomatic Infections, run by Hôpital Européen Marseille at 1 site in France.
Trial summary
Screening for genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Genital Infection, Asymptomatic Infections
- What is being tested?
- Vaginal self-sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,028 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2015to 6 Apr 2018
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women requiring vaginal or cervical classical sampling to screen for genital infections
- Women requiring vaginal or cervical classical sampling to screen for sexually transmitted infections (STI)
- Pregnant women requiring vaginal classical sampling to screeen for Group B streptococcus asymptomatic carriage in the eighth month of pregnancy
- Informed written consent from the patient
Who cannot join
- Person subjected to therapeutic limitation decision
- Women with intact hymen
- Active antibiotic or antifungic treatment
- Antiobiotic or antifungic treatment during the 10 days prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial
Screening for genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Vaginal self-sampling (VSS) has progressively emerged as an alternative to VCS for STI agent screening. The use of vaginal self-sampling (VSS) could facilitate follow-ups and potentially help in the prevention of gynaecological disorders.
- Conditions
- Genital Infection, Asymptomatic Infections
- Being tested
- Vaginal self-sampling
- Keywords
- Vaginal self-sampling, STI, Genital infection, Group B streptococcus
- Medical subject headings
- Asymptomatic Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal self-samplingProcedure or surgery
The objective is to determine the non-inferiority of vaginal self-sampling compared with vaginal/cervical classical sampling, and evaluate the possibility of using it in all clinical situations indicating the prescription of such a procedure to screen for genital infections (GIs), sexually transmitted infections (STIs) and group B streptococcus (GBS) asymptomatic carriage in pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Genital infections | Other | Women with vaginal/cervical sampling indications Receives: Procedure: Vaginal self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial infection detection rates
Bacterial infection detection rates of VSS compared with VCS
Measured: 10 days
Yeast infection detection rates
Yeast infection detection rates of VSS compared with VCS
Measured: 10 days
Chlamydia trachomatis detection rates
Chlamydia trachomatis detection rates of VSS compared with VCS
Measured: 10 days
Neisseria gonorrhoeae detection rates
Neisseria gonorrhoeae detection rates of VSS compared with VCS
Measured: 10 days
Mycoplasma genitalium detection rates
Mycoplasma genitalium detection rates of VSS compared with VCS
Measured: 10 days
Trichomonas vaginalis detection rates
Trichomonas vaginalis detection rates of VSS compared with VCS
Measured: 10 days
Human simplex virus detection rates
Human simplex virus detection rates of VSS compared with VCS
Measured: 10 days
Group B streptococcus detection rates
Group B streptococcus detection rates of VSS compared with VCS
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start20 Oct 2015
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genital 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
- Participants were screenned for genital infections * performing vaginal and/or cervical classical-sampling (VCS) * performing vaginal self-sampling (VSS)
- Masking
- None (open label)
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin QUARELLO @me.com, Hôpital Européen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039711
- Sponsor's protocol ID
- RCB 2014-A01250-47
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, Schachter J, Holmes KK, Martin DH. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d.
PubMed 18157061Lunny 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 26168051
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vaginal Self-sampling Diagnostic Performances to Identify Genital Infections : A Large, Cross-sectional, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04039711
- Acronym / sponsor ID
- RCB 2014-A01250-47
- Conditions
- Genital Infection, Asymptomatic Infections
- Keywords
- Vaginal self-sampling, STI, Genital infection, Group B streptococcus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 31 Jul 2019 (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 genital infection (GI), sexually transmitted infection (STI) and asymptomatic carriage of group B streptococcus (GBS) in pregnant women is a common reason for medical appointments. Conventional testing is performed by using vaginal and/or cervical classic sampling (VCS). Vaginal self-sampling (VSS) has progressively emerged as an alternative to VCS for STI agent screening. The use of vaginal self-sampling (VSS) could facilitate follow-ups and potentially help in the prevention of gynaecological disorders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants were screenned for genital infections * performing vaginal and/or cervical classical-sampling (VCS) * performing vaginal self-sampling (VSS)
| Arm | Type | Receives |
|---|---|---|
| Genital infections | Other | Procedure: Vaginal self-samplingWomen with vaginal/cervical sampling indications |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women requiring vaginal or cervical classical sampling to screen for genital infections
- Women requiring vaginal or cervical classical sampling to screen for sexually transmitted infections (STI)
- Pregnant women requiring vaginal classical sampling to screeen for Group B streptococcus asymptomatic carriage in the eighth month of pregnancy
- Informed written consent from the patient
Key exclusion criteria (4 listed)
- Person subjected to therapeutic limitation decision
- Women with intact hymen
- Active antibiotic or antifungic treatment
- Antiobiotic or antifungic treatment during the 10 days prior to inclusion
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 self-samplingThe objective is to determine the non-inferiority of vaginal self-sampling compared with vaginal/cervical classical sampling, and evaluate the possibility of using it in all clinical situations indicating the prescription of such a procedure to screen for genital infections (GIs), sexually transmitted infections (STIs) and group B streptococcus (GBS) asymptomatic carriage in pregnant women. | Procedure or surgery | Genital infections |
Primary outcome
Bacterial infection detection rates
Time frame: 10 days
Bacterial infection detection rates of VSS compared with VCS
Yeast infection detection rates
Time frame: 10 days
Yeast infection detection rates of VSS compared with VCS
Chlamydia trachomatis detection rates
Time frame: 10 days
Chlamydia trachomatis detection rates of VSS compared with VCS
Neisseria gonorrhoeae detection rates
Time frame: 10 days
Neisseria gonorrhoeae detection rates of VSS compared with VCS
Mycoplasma genitalium detection rates
Time frame: 10 days
Mycoplasma genitalium detection rates of VSS compared with VCS
Trichomonas vaginalis detection rates
Time frame: 10 days
Trichomonas vaginalis detection rates of VSS compared with VCS
Human simplex virus detection rates
Time frame: 10 days
Human simplex virus detection rates of VSS compared with VCS
Group B streptococcus detection rates
Time frame: 10 days
Group B streptococcus detection rates of VSS compared with VCS
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 2 Aug 2019.
- Results publication: PubMed 18157061Hobbs MM, van der Pol B, Totten P, Gaydos CA, Wald A, Warren T, Winer RL, Cook RL, Deal CD, Rogers ME, Schachter J, Holmes KK, Martin DH. From the NIH: proceedings of a workshop on the importance of self-obtained vaginal specimens for detection of sexually transmitted infections. Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d.
- Results publication: 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal self-sampling in people with Genital Infection and Asymptomatic Infections, run by Hôpital Européen Marseille 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 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 2 Aug 2019. 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?
Bacterial infection detection rates (time frame: 10 days). The study lists 8 primary outcomes in all. 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 NCT04039711, which also lists 2 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 2 Aug 2019.