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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00682851 |
This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).
Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. THis study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.
Condition | Intervention |
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Bacterial Vaginosis Trichomonas Vaginalis |
Device: OSOM Trichomonas Rapid Test Device: OSOM BVBlue Test |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Active Control, Single Group Assignment |
Official Title: | A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test |
Estimated Enrollment: | 500 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ingrid Macio, PA-C | 412-641-5455 | imacio@mail.magee.edu |
Contact: Jamie Haggerty | 412-641-5378 | jhaggerty@mail.magee.edu |
United States, Pennsylvania | |
Magee-Womens Hospital of UPMC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Principal Investigator: Sharon L Hillier, PhD |
Principal Investigator: | Sharon L Hillier, PhD | University of Pittsburgh |
Responsible Party: | University of PIttsburgh ( Sharon L. Hillier, PhD ) |
Study ID Numbers: | PRO08020012 |
Study First Received: | May 16, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00682851 |
Health Authority: | United States: Institutional Review Board |
Genital Diseases, Female Bacterial Infections Vaginosis, Bacterial Vaginitis Vaginal Diseases |