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

Tracking Information

First Received Date ^ICMJE

May 16, 2008

Last Updated Date

April 14, 2009

Start Date ^ICMJE

July 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00682851 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Official Title ^ICMJE

A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Active Control, Single Group Assignment

Condition ^ICMJE

Bacterial Vaginosis
Trichomonas Vaginalis

Intervention ^ICMJE

Device: OSOM Trichomonas Rapid Test
Device: OSOM BVBlue Test

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

500

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

15 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00682851

Responsible Party

Sharon L. Hillier, PhD, University of PIttsburgh

Study ID Numbers ^ICMJE

PRO08020012

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Sharon L Hillier, PhD

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP