Bacterial VaginosisNCT00682851

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

An observational study of Bacterial Vaginosis and Urogenital Infection by Trichomonas Vaginalis, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 to diagnose common vaginal infections. Read more about this study

Who is it for?: Ages 15 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Bacterial Vaginosis, Urogenital Infection by Trichomonas Vaginalis
What is being tested?: OSOM Trichomonas Rapid Test and OSOM BVBlue Test
Type of treatment: Medical device
How many people: 519 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Apr 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Non-pregnant women between the ages of 18 and 60, with or without symptoms of vaginitis, were recruited for this study from Magee-Womens Hospital of University of Pittsburgh Medical Center and Allegheny County Health Department.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Bacterial Vaginosis, Urogenital Infection by Trichomonas Vaginalis
Being tested: OSOM Trichomonas Rapid Test, OSOM BVBlue Test
Medical subject headings: Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OSOM Trichomonas Rapid TestDevice
Rapid test run using vaginal discharge collected via a cotton swab
OSOM BVBlue TestDevice
Rapid test run using vaginal discharge collected using a cotton swab

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.
Measured: Visit 1

Secondary outcomes (3)

Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.
Measured: Visit 1
Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.
Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.
Measured: Visit 1
Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.
Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.
Measured: Visit 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Apr 2009

First posted22 May 2008 (estimated)
Study startJul 2008
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 519 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00682851
Sponsor's protocol ID: PRO08020012
Status last verified: Aug 2016
First submitted: 16 May 2008
Last updated: 22 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

All Bacterial Vaginosis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
ClinicalTrials.gov ID: NCT00682851
Acronym / sponsor ID: PRO08020012
Conditions: Bacterial Vaginosis, Urogenital Infection by Trichomonas Vaginalis
Study type: Observational
Recruitment status: Completed
Enrolment: 519 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Study start: Jul 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 22 May 2008 (estimated)
Results: Posted 8 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 15 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Non-pregnant women between the ages of 18 and 60, with or without symptoms of vaginitis, were recruited for this study from Magee-Womens Hospital of University of Pittsburgh Medical Center and Allegheny County Health Department.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OSOM Trichomonas Rapid TestRapid test run using vaginal discharge collected via a cotton swab	Device	–
OSOM BVBlue TestRapid test run using vaginal discharge collected using a cotton swab	Device	–

Primary outcome

Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Time frame: Visit 1
Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.

3 secondary outcomes

Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Time frame: Visit 1
Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.
Time frame: Visit 1
Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.
Time frame: Visit 1

Results and safety

Results posted to the registry on 8 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symptomatic	251	251
Asymptomatic	268	268

Primary outcome: Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women

Time frame: Visit 1. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Symptomatic n = 251	Asymptomatic n = 268
OSOM Rapid Test	92 (78 to 98)	91 (72 to 99)
PCR	100 (90 to 100)	100 (85 to 100)
Wet Mount Microscopy	58 (41 to 74)	48 (27 to 69)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symptomatic	0 of 251 (0%)	0 of 251 (0%)	Not reported
Asymptomatic	0 of 268 (0%)	0 of 268 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Bacterial Vaginosis

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sharon L Hillier, PhD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bacterial Vaginosis and Urogenital Infection by Trichomonas Vaginalis, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women (time frame: Visit 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00682851.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.