Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Condition: Vaginitis Gardnerella
MeSH terms: Vaginosis, Bacterial; Vaginitis
Intervention: Amoxicillin; Placebo
Intervention description: Amoxicillin is an aminopenicillin antibiotic; Placebo
Intervention MeSH terms: Amoxicillin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 97.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amoxicillin; Gardnerella vaginalis; Vaginal Colonization

Summary:

      This is a randomized, double-blind, placebo-controlled Phase 2 study designed to determine if
      amoxicillin will eradicate vaginal colonization/infection with Gardnerella vaginalis (GV)
      when administered to women who are colonized/infected with GV but have no clinical evidence
      of Bacterial Vaginosis (BV). The study will be conducted at 2 clinics in the United States:
      University of Alabama at Birmingham and Wake Forest University Health Sciences. Entire study
      duration is approximately 24 months and subject participation duration is approximately 22
      days. Approximately 245 healthy adult females, 18 to 45 years of age will be screened to
      enroll approximately 98 participants to achieve 82 evaluable participants at the test of cure
      (ToC) visit. Participants will be enrolled and randomized to one of two groups, either
      amoxicillin (2 x 250 mg capsules by mouth twice daily for 7 days) or placebo. Women who are
      enrolled will be asked to return for one further visit, Visit 2 (Day 15 - 21), where a ToC
      will be completed. For those not enrolled, participation will end at their post screening
      follow up phone call. Women will be asked to use condoms during their participation. The
      primary objective is to determine if treatment with amoxicillin eradicates GV in women who
      are colonized/infected with GV but have no clinical evidence of BV.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women ages 18-45, inclusive.

          2. No evidence of vaginitis (yeast, trichomonas, and BV/abnormal vaginal flora) or other
             vaginal conditions which in the opinion of the investigator could be confounders*.

             *These causes will initially be detected by wet mount microscopy with trichomonas
             during the screening procedures and later confirmed by NAAT and BV/abnormal vaginal
             flora confirmed by Nugent scoring (Nugent score of 4-10).

          3. Presence of GV detected by NAAT*.

             *Results of NAAT testing will be available prior to return for Enrollment visit.

          4. Willing to use condoms during vaginal intercourse while participating in the study.

          5. Not currently menstruating at screening visit.

          6. Willing and able to provide written informed consent.

          7. Negative urine pregnancy test on all participants of childbearing potential at study
             screening.

          8. Participant must be of non-childbearing potential* or must be using highly effective
             birth control** to avoid becoming pregnant.

             *Non-childbearing potential is defined as being post-menopausal for at least 1 year,
             status after bilateral tubal ligation, or status after bilateral oophorectomy or
             status after hysterectomy.

             **In addition to the required use of condoms by the male partner during study
             participation, participants must agree to avoid becoming pregnant by using one of the
             following acceptable method of birth control for 30 days prior to screening and for
             the duration of the study:

               -  Intrauterine contraceptive device; OR

               -  Oral contraceptives; OR

               -  Hormonal injections; OR

               -  Hormonal implants; OR

               -  Contraceptive patches; OR

               -  Monogamous relationship with vasectomized partner; OR

               -  Exclusively same-sex relationships; OR

               -  Abstinence

          9. Participant is not planning on taking antibiotics or using any intravaginal
             microbicides from the Screening visit through the Visit 2 Follow-up (TOC).

         10. Participant is willing and able to cooperate to the extent and degree required by this
             protocol at the discretion of the investigator.

        Exclusion Criteria:

          1. Pregnant or nursing.

          2. Allergic to penicillin, amoxicillin, cephalosporins, or other ß-lactam antibiotic.

          3. Use of antibiotics in the past 14 days prior to screening visit.

          4. HIV infected.

          5. Women taking immunosuppressive agents.

        7. History of renal impairment. 8. Use of any investigational drug within the past 30 days
        prior to screening. 9. Any other condition that, in the opinion of the investigator, would
        interfere with participation in the study.