Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Condition: Recurrent Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with
      metronidazole or placebo to compare the rates of recurrent BV in the women
    

Detailed description: 
      This study will be performed as a phase III randomized, double-blinded trial to evaluate the
      efficacy of 1) metronidazole 500 mg PO BID for 7 days versus 2) placebo capsules alone for
      treatment of the male sexual partner of women with recurrent BV. The primary outcome is the
      rates of recurrent BV between these two groups. Although this is a phase III study we will
      carefully monitor potential toxicity in the males since it is currently not standard of care
      to treat males for this indication.

      Women with symptomatic BV defined by Amsel criteria 1 and no evidence of STD will be invited
      to participate. Inclusion criteria are that the woman be at least 18 years of age,
      heterosexual, have symptoms of vaginal odor and/or discharge, meet the modified clinical
      (Amsel) criteria for BV (all must have a vaginal pH of >4.5, a positive whiff test, and clue
      cells to be eligible), have an enrollment Nugent score of 7 or greater, and a history of 2 or
      more episodes of BV in the previous year. She must have a regular current sex partner who
      would be willing to participate. We will exclude women who have had recurrent BV for greater
      than 3 years as well as women who have failed previous treatment studies since it is likely
      that these women are having recurrent BV as a result of relapse of the BV biofilm as opposed
      to reinfection.

      Follow-up visits will be conducted at day 21, 8 and 16 weeks. At each follow-up visit, a
      questionnaire will be administered, diary reviewed, pelvic examination conducted and
      specimens (Gram stain, Amsel criteria, G vaginalis culture and detection of novel organisms)
      obtained as done at the enrollment visit. Participants will be asked to return the medication
      packages, a standard way of assessing adherence to the regimen. Cure will be ascertained
      using the clinical criteria for BV of Amsel 1 as well as the Nugent scoring system 16. The
      persistence or disappearance of specific organisms will be analyzed in relationship to these
      standard definitions of cure. Women who fail initial therapy or have recurrence of
      symptomatic BV during the course of the study will be re-treated with 7 days of metronidazole
      and dropped from the study at that time. Any woman found to have a positive screening test
      for gonorrhea or chlamydia will be treated appropriately and instructed to notify her partner
      of the need to be treated. Women with intercurrent vaginal yeast infections, which may occur,
      will be treated with oral fluconazole and continued in the study. Women with a positive
      culture for trichomonas will be dropped from the study as their male partners will require
      treatment with metronidazole.

      Male Study Procedures

      Males referred by their female sexual partner will be seen within 48 hours of enrollment of
      the female. Males will be consented and asked behavioral and historical questions using a
      gender appropriate questionnaire, with special emphasis on number of current sexual partners.
      A couple verification screening tool will be utilized to be certain they are current sexual
      partners48. The confidentiality of their answers will be emphasized. They will be examined
      and a urethral swab specimen obtained to be used for G vaginalis culture and then archived.
      Following the swabs, two external swabs from the coronal sulcus and a 10 ml first void urine
      specimen will be obtained. These specimens will also be used for G vaginalis culture and
      archived for possible use in detection of novel organisms. The urine will also be used for
      NAATS for N gonorrhoeae and C trachomatis and for the determining the presence or absence of
      Gardnerella biofilm24. They will then be randomized to one of two treatment arms:

        1. Metronidazole 500 mg PO twice a day for 7 days .

        2. Placebo capsules PO twice a day for 7 days.

      Both arms will also contain an instruction sheet on metronidazole.
    

Intervention name(s): Metronidazole (male partner); Placeob (male partner)
Intervention type(s): Drug; Other
Intervention description(s): 500 mg PO BID for 7 days; matching placebo capsules PO BID for 7 days
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: bacterial vaginosis; recurrence; male partner