Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Status:
Completed
Trial end date:
2019-08-22
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)