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Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin

Primary Purpose

Vaginitis Gardnerella

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amoxicillin
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginitis Gardnerella focused on measuring Amoxicillin, Gardnerella vaginalis, Vaginal Colonization

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

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

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo arm

Treatment arm

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 6, 2017
Last Updated
August 13, 2020
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03211156
Brief Title
Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Official Title
A Randomized, Double-Blind, Placebo Controlled, Phase 2 Study to Assess Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Study Type
Interventional

2. Study Status

Record Verification Date
June 28, 2017
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginitis Gardnerella
Keywords
Amoxicillin, Gardnerella vaginalis, Vaginal Colonization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo 2 capsules PO twice a day for 7 days, n=49
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Amoxicillin 2 x 250 mg capsules PO twice a day for 7 days, n=49
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Amoxicillin is an aminopenicillin antibiotic
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Day 15 to 21
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 1 through Day 15 to 21

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Alabama at Birmingham School of Medicine - Infectious Disease
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Guilford County Health Department - Greensboro - STD Clinic
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin

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