A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test - Full Text View

Purpose

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
Bacterial Vaginosis Trichomonas Vaginalis	Device: OSOM Trichomonas Rapid Test Device: OSOM BVBlue Test

U.S. FDA Resources

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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

To compare the sensitivity and specificity of the OSOM Test to wet mount microscopy, Trichomonas culture, and PCR in diagnosing Trichomonas vaginalis [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the sensitivity and specificity of the BVBlue Test to Amsel criteria and Gram Stain (Nuget scoring) in diagnosing BV. [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

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)

Intervention Details:

Rapid test run using vaginal discharge collected via a cotton swab

rapid test run using vaginal discharge collected using a cotton swab

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

At least 15 years of age at time of enrollment
Ability to provide written informed consent

Exclusion Criteria:

Currently menstruating or bleeding
Use of an antibiotic to treat BV or Trichomonas within the past 7 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682851

Contacts


Contact: Ingrid Macio, PA-C	412-641-5455	imacio@mail.magee.edu

Contact: Jamie Haggerty	412-641-5378	jhaggerty@mail.magee.edu

Locations


United States, Pennsylvania
	Magee-Womens Hospital of UPMC	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Principal Investigator: Sharon L Hillier, PhD

Sponsors and Collaborators

University of Pittsburgh

Investigators


Principal Investigator:	Sharon L Hillier, PhD	University of Pittsburgh

More Information

Responsible Party:	University of PIttsburgh ( Sharon L. Hillier, PhD )
Study ID Numbers:	PRO08020012
First Received:	May 16, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00682851
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Genital Diseases, Female

Bacterial Infections

Vaginosis, Bacterial

Vaginitis

Vaginal Diseases

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00682851