Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wayne State University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Metronidazole; Miconazole

Criteria

Inclusion Criteria:

Inclusion Criteria For BV Subjects: (140 subjects)

• Premenopausal women over the age of 18 who have BV who are willing to sign informed consent.

• Positive for all Amsel criteria:

• Vaginal pH > 4.5

• Positive amine test

• > 20% clue cells on wet mount

• Grayish-white adherent discharge

• Subject is willing to refrain from using any vaginal medications, douches or spermicides except for the metronidazole suppositories that are given to her for the duration of the study.

• Subject is willing to use supplied non-lubricated condoms when sexually active. But not to have sexual intercourse within 48 hours of any Study Visit.

• Subject to refrain from alcohol for 24 hours prior to the first 7 days of the metronidazole treatment and for 48 hours after completion of this treatment.

Inclusion criteria for Healthy control group.

• Enrollees for the healthy Group H in the study must be premenopausal and have not experienced any vaginitis in the past year.

• Subject will be encouraged to have a full clinical examination, but if she declines, she must have a self-swab evaluation that is normal (no yeast, no clue cells, normal flora, no parabasal cells and no trichomonads) and will be retained in Group H if her Nugent score is 3 or less.

• Subject must be willing to obtain daily samples and return monthly with the samples for a self-swab evaluation and a replenishment of the daily swab supplies. Healthy women will continue for as long as they are willing up to 9 months.

• Healthy women will be asked to use the supplied non-lubricated condoms, but will not be dropped from the study if they do not.

• Must be using some form of contraception if sexually active.

Exclusion Criteria:

Study Exclusion Criteria for BV Study Subjects:

• Mixed vaginal infection at time of enrollment.

• Pregnancy, nursing or planning on getting pregnant.

• Subject on anticoagulation therapy, lithium therapy or Antabuse therapy.

• Vaginal bleeding at time of enrollment

• Allergy to metronidazole

• Use of any vaginal antibiotics or antifungals in the previous 10 days, from enrollment.

• Must not require treatment for an abnormal Pap smear or genital cancer.

• Must abstain from vaginal douching during enrolled period.

Study Exclusion for Control Subjects:

• Has a vaginal infection at enrollment

• Pregnant, nursing or planning on becoming pregnant in the next year.

• Vaginal bleeding at enrollment

• Must not require treatment of any genital cancer or abnormal pap smear

• Should abstain from douching throughout the length of the study.