Status:
UNKNOWN
Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18-55 years
Phase:
EARLY_PHASE1
Brief 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-...
Detailed Description
A standard of care (SOC) treatment for BV is oral metronidazole 500 mg twice a day for 7 days (8). The investigators will use this for all enrollees with BV as the initial treatment. The investigators...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02185456
Start Date
September 1 2014
End Date
March 1 2016
Last Update
November 7 2014
Active Locations (1)
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1
WSU Tolan Park Medical Building 3901 Chrysler Service Drive, Suite 4A
Detroit, Michigan, United States, 48201