- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03211156
Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
A Randomized, Double-Blind, Placebo Controlled, Phase 2 Study to Assess Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
- University of Alabama at Birmingham School of Medicine - Infectious Disease
-
-
North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Guilford County Health Department - Greensboro - STD Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo arm
Placebo 2 capsules PO twice a day for 7 days, n=49
|
Placebo
|
Experimental: Treatment arm
Amoxicillin 2 x 250 mg capsules PO twice a day for 7 days, n=49
|
Amoxicillin is an aminopenicillin antibiotic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Proportion of Participants With Eradication of Gardnerella Vaginalis (GV) in Each Study Arm at Visit 2 (Day 15-21) as Assessed by Nucleic Acid Amplification Test (NAAT).
Time Frame: Day 15 to 21
|
Eradication of GV is defined by a negative NAAT result for GV at Visit 2. Participants who have a missing GV NAAT result at the test of cure (TOC) visit were classified as treatment failures.
The denominator for proportions is based on the number of subjects who were randomized to the specified treatment group.
|
Day 15 to 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Proportion of Participants Reporting Related Adverse Events (AEs and SAEs) in Each Study Arm Following the First Dose of Study Product Through Visit 2.
Time Frame: Day 1 through Day 15 to 21
|
AEs were defined as any untoward medical occurrence in a participant administered a pharmaceutical product.
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.
AEs and SAEs were collected from participants following the first dose of treatment through Visit 2 (Day 15-21).
Events are included if deemed by the investigator to be related to the study product.
|
Day 1 through Day 15 to 21
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-0073
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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