Trial · NCT02185456
Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
NCT02185456, Early phase 1, Unknown, Wayne State University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis. Trials, record NCT02185456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02185456
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
- NCT number
- NCT02185456
- Status
- Unknown
- Phases
- Early phase 1
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Wayne State University
- Conditions
- Bacterial Vaginosis
- Interventions
- 750 mg metronidazole/ 200 mg miconazole vaginal suppository, Standard of care
- First posted
- 2014-07-09
- Last updated
- 2014-11-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diagnosis of bacterial vaginosis | Monthly for up to nine months | Patients and control women will be assessed monthly for bacterial vaginosis by Nugent and Amsel criteria |
| Secondary | Relative quantity of Lactobacillus among total vaginal bacteria | Monthly clinical visits and daily swabs for up to nine months | This quantitative assay of relative Lactobacillus content of vaginal swabs will be assessed monthly by qPCR, from samples taken at the clinic and from daily self swabs. This will be reported as a score, which is proportional to percentage Lactobacillus, and also integrates a score which reflects the prevalence of mid to low levels of non-Lactobacillus species. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AI111103 | Validation of a novel diagnostic, prognostic assay for bacterial vaginosis | AKINS, ROBERT A | WAYNE STATE UNIVERSITY | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2014 to 2015 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02185456
GET https://conductscience.org/api/trials/v1/NCT02185456/registered