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

This study has been completed.

Study NCT00682851 Information provided by University of Pittsburgh

First Received on May 16, 2008. Last Updated on August 25, 2011 History of Changes

Results First Received: July 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Conditions:	Bacterial Vaginosis Urogenital Infection by Trichomonas Vaginalis
Interventions:	Device: OSOM Trichomonas Rapid Test Device: OSOM BVBlue Test

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Symptomatic	Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
Asymptomatic	Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).

Participant Flow: Overall Study

	Symptomatic	Asymptomatic
STARTED	251	268
COMPLETED	251	268
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Symptomatic	Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.
Asymptomatic	Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).

Baseline Measures

	Symptomatic	Asymptomatic	Total
Number of Participants [units: participants]	251	268	519
Age [units: participants]
<=18 years	12	16	28
Between 18 and 65 years	239	252	491
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	28.3 ± 8.2	27.0 ± 8.7	27.6 ± 8.6
Gender [units: participants]
Female	251	268	519
Male	0	0	0
Region of Enrollment [units: participants]
United States	251	268	519

Outcome Measures

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1. Primary:

Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women [ Time Frame: Visit 1 ]

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2. Secondary:

Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women [ Time Frame: Visit 1 ]

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3. Secondary:

Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. [ Time Frame: Visit 1 ]

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4. Secondary:

Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women. [ Time Frame: Visit 1 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A major limitation of this study was that in the first 122 women, 24% of the cohort, the vaginal swabs used for the diagnostic tests were collected in random order, which resulted in decreased sensitivity of the OSOM Rapid and BVBLue tests.

Results Point of Contact:

Name/Title: Lorna Rabe
Organization: Magee-Womens Research Institute
phone: 412-641-6042
e-mail: lrabe@mwri.magee.edu

No publications provided

Responsible Party:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00682851 History of Changes
Other Study ID Numbers:	PRO08020012
Study First Received:	May 16, 2008
Results First Received:	July 8, 2011
Last Updated:	August 25, 2011
Health Authority:	United States: Institutional Review Board