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ISRCTN
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ISRCTN42867448
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ClinicalTrials.gov identifier
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Public title
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Self-taken vaginal swabs and gonorrhoea detection
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Scientific title
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Comparison of self-taken vaginal swabs versus clinician taken urethral and endocervical swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay
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Acronym
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N/A
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Serial number at source
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7293
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Study hypothesis
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This is a prospective cohort study to compare self-taken vaginal swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay versus clinician taken urethral and endocervical swabs for the detection of gonorrhoea by standard culture. Furthermore, we will assess the cost effectiveness of the different methods of detecting gonorrhoea.
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Lay summary
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Ethics approval
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Leeds (East) Research Ethics Committee approved on the 3rd February 2009 (ref: 09/H1306/4)
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Study design
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Single centre randomised interventional screening trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology
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Participants - inclusion criteria
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1. Women aged 16 years and over
2. Presenting for a new or re-registration visit
3. Wish to be tested for both chlamydia and gonorrhoea
4. Give consent
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Participants - exclusion criteria
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1. Women who are unwilling or unable to give verbal consent
2. Women who have taken antibiotics in the previous 28 days
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Anticipated start date
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01/03/2009
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Anticipated end date
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31/01/2010
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Status of trial
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Completed |
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Patient information material
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'Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 4000
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Interventions
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A self taken vulvo-vaginal swab analysed for gonorrhoea by the Aptima Combo 2 assay, followed by clinician taken urethral and endocervical samples analysed for gonorrhoea by culture then an endocervical sample analysed for gonorrhoea by the Aptima Combo 2 assay. All positive Aptima Combo 2 assays for gonorrhoea will be confirmed using the Aptima GC assay.
The cost of each procedure will be assessed including the cost of the test and staff time.
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Primary outcome measure(s)
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Sensitivity, specificity, positive and negative predictive values of the Gen-Probe Aptima Combo 2 assay for the detection of gonorrhoea using self-taken vaginal swabs compared with clinician taken urethral and endocervical swabs for the detection of gonorrhoea by standard culture.
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Secondary outcome measure(s)
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Sensitivity, specificity, positive and negative predictive values of self-taken vaginal swabs compared with clinician taken endocervical swabs for the detection of gonorrhoea using the Gen-Probe Aptima Combo 2 assay.
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Sources of funding
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Gen-Probe Inc. (USA)
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Trial website
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Publications
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Contact name
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Dr
Janet
Wilson
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Address
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Department of Genito-Urinary Medicine
Sunnybank Wing
Leeds General Infirmary
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Sponsor
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Leeds Teaching Hospitals NHS Trust (UK)
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Address
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Research and Development Department
34 Hyde Terrace
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City/town
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Leeds
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Zip/Postcode
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LS2 9LN
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Country
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United Kingdom
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Sponsor website:
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http://www.leedsteachinghospitals.com/
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Date applied
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24/06/2010
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Last edited
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06/07/2010
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Date ISRCTN assigned
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24/06/2010
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