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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00682851
First received: May 16, 2008
Last updated: August 25, 2011
Last verified: August 2011
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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).
Total Total of all reporting groups

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
  Show All Outcome Measures

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 ]

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 ]

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

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


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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