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G2. Molecular conversion subarm for Bacterial Vaginosis (BV-LbRC Trial)

Phase < 1
Waitlist Available
Led By Robert A Akins, PhD
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly clinical visits and daily swabs for up to nine months
Awards & highlights

BV-LbRC Trial Summary

Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three months and 70-80% within a year. Given the paucity of information and data regarding pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown. Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are not available. In 2013, the investigators published two manuscripts documenting a new qPCR based approach to BV diagnosis and potentially prognosis. The method (LbRC) measures the content of lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this study are to validate that this metric is a reliable diagnostic of BV, by determining sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is to determine whether empirically determined "low" LbRC scores (1-2) in BV patients after treatment are indicators of recurrence, and whether preemptive action, based on this score, with more intensive treatment, delays or eliminates recurrence in these patients.

Eligible Conditions
  • Bacterial Vaginosis

BV-LbRC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for up to nine months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for up to nine months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnosis of bacterial vaginosis
Secondary outcome measures
Pap smear

BV-LbRC Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: G2. Molecular conversion subarmExperimental Treatment2 Interventions
Half of G1 patients who convert to poor qPCR test results while remaining asymptomatic will be randomized into this G2 arm and receive intervention: 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days, with continued monthly visits and daily swabs.
Group II: B2 BV Remission to conversionExperimental Treatment2 Interventions
A subgroup of B1 patients who convert to consistently poor qPCR scores during the study (conversion) will be randomized into Arm B2 and receive intervention: 750 mg metronidazole/ 200 mg miconazole vaginal suppository daily for 7 days. These patients will continue monthly visits and daily self swabs. B2 patients who recur with symptomatic BV will be dropped from the study and given other options for therapy.
Group III: HealthyActive Control1 Intervention
Patients with no history of bacterial vaginosis. These women will be monitored monthly and with daily self swabs.
Group IV: G1 BV in clinical & molecular remissionActive Control1 Intervention
Patients will receive standard of care intervention, oral metronidazole 500 mg twice a day for 7 days. They will then be monitored to confirm that initial BV treatment was effective by Nugent and Amsel, and by the qPCR test (LbRC). These will be monitored with monthly visits and daily self swabs. Those who recur with symptomatic BV may enroll in the B2 arm for more aggressive treatment.
Group V: B1 Initially poor qPCR respondersActive Control1 Intervention
The B1 arm are patients who enter remission after standard of care treatment, oral metronidazole 500 mg twice a day for 7 days, but who have poor initial qPCR scores. Half of such patients will be randomized into B1, half into B2. B1 patients will be monitored with monthly visits and via daily swabs, but will receive no further treatment while BV negative. Patients who recur with BV may enroll as B2 patients for more aggressive treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metronidazole
FDA approved

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,283 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,269 Total Patients Enrolled
Robert A Akins, PhDPrincipal InvestigatorWayne State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
Robert A. Akins 2014. "Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02185456.
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~19 spots leftby Apr 2025
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