Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Vaginitis Gardnerella
About this trial
This is an interventional treatment trial for Vaginitis Gardnerella focused on measuring Amoxicillin, Gardnerella vaginalis, Vaginal Colonization
Eligibility Criteria
Inclusion Criteria:
- Women ages 18-45, inclusive.
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).
Presence of GV detected by NAAT*.
*Results of NAAT testing will be available prior to return for Enrollment visit.
- Willing to use condoms during vaginal intercourse while participating in the study.
- Not currently menstruating at screening visit.
- Willing and able to provide written informed consent.
- Negative urine pregnancy test on all participants of childbearing potential at study screening.
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
- Participant is not planning on taking antibiotics or using any intravaginal microbicides from the Screening visit through the Visit 2 Follow-up (TOC).
- Participant is willing and able to cooperate to the extent and degree required by this protocol at the discretion of the investigator.
Exclusion Criteria:
- Pregnant or nursing.
- Allergic to penicillin, amoxicillin, cephalosporins, or other ß-lactam antibiotic.
- Use of antibiotics in the past 14 days prior to screening visit.
- HIV infected.
- 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.
Sites / Locations
- University of Alabama at Birmingham School of Medicine - Infectious Disease
- Guilford County Health Department - Greensboro - STD Clinic
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo arm
Treatment arm
Placebo 2 capsules PO twice a day for 7 days, n=49
Amoxicillin 2 x 250 mg capsules PO twice a day for 7 days, n=49