Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Condition: Vaginitis Gardnerella
MeSH terms: Vaginosis, Bacterial; Vaginitis
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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. Women who consent to screening participation will undergo pelvic examination on
      entry and vaginal specimens collected for pH, whiff test and wet prep microscopy (Amsel
      criteria with the exception of evaluation of vaginal discharge), Nugent score, nucleic acid
      amplification test (NAAT) for trichomonas, quantitative NAAT for GV, and microbiome analysis.
      At Visit 1 (Enrollment - Day 1), women who tested positive for GV by NAAT, negative for BV by
      Nugent, and negative for trichomonas by NAAT 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 (a pelvic exam completed with the same specimens taken as those
      at baseline with the exception of the trichomonas NAAT). 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. The secondary objective is to evaluate the safety and tolerability
      of amoxicillin compared to placebo.
    

Intervention name(s): Amoxicillin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Amoxicillin is an aminopenicillin antibiotic; Placebo
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amoxicillin; Gardnerella vaginalis; Vaginal Colonization