NCT03151928|Completed
Diagnostic Accuracy By Providers Study
DAP
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DAP
Sponsor study identifier
observational
299
1 country
1
Study Start
July 6, 2017
Actual (reported)Primary Completion
August 15, 2018
Actual (reported)Study Completion
August 15, 2018
Actual (reported)The validation study is intended to provide comparative data on the diagnosis of vaginal infections as performed in primary care settings versus the diagnosis provided through standard diagnostic testing performed in a reference laboratory. The clinician and lab diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX System.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 15, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 10, 2017
Actual (reported)May 12, 2017
Actual (reported)July 6, 2017
Actual (reported)August 15, 2018
Actual (reported)August 15, 2018
Actual (reported)BV Result Agreement
Comparison of the level of agreement of clinician diagnosed BV to vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal Panel
enrollment
Trichomonas (TV) Result Agreement
Comparison of the level of agreement of clinician diagnosed TV to the laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by Cepheid and the BD MAX Vaginal Panel
enrollment
Yeast Result Agreement
Comparison of the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the BD MAX Vaginal Panel
enrollment
Patterns of clinician testing
enrollment
Prescribed Treatments
enrollment
Women with vaginitis seeking routine care will be approached to have five additional swabs collected during their pelvic exam * vaginal swab for qualitative PCR using the BD Max Vaginal Panel on the automated BDMAX System * Vaginal smear for evaluation with Gram's stain and Nuget's criteria * Vaginal swab for yeast culture * Vaginal swab for Trichomonas vaginalis NAAT * Vaginal swab for discrepant analysis testing
The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Women presenting to primary care offices with symptoms of vaginitis
Magee-Womens Hospital of UPMC/associated community clinics
Pittsburgh, Pennsylvania, 15213, United States
Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis. 2021 May 4;72(9):1538-1543. doi: 10.1093/cid/ciaa260.
Sharon L Hillier, PhD
University of Pittsburgh
299 participants (actual enrollment reported by the registry).
First Submitted
May 10, 2017
First Posted
May 12, 2017
Study Start
July 6, 2017
Actual (reported)Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
Contact the study team to confirm eligibility.
Primary Completion
August 15, 2018
Actual (reported)Study Completion
August 15, 2018
Actual (reported)Last Updated
October 4, 2018
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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