Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin - Full Text View

Purpose

This is a randomized, double-blind, placebo-controlled pilot 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 10 months and subject participation duration is approximately 15 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.

Condition	Intervention	Phase
Vaginitis Gardnerella	Drug: Amoxicillin Other: Placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo Controlled, Pilot Study to Assess Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin

Resource links provided by NLM:

MedlinePlus related topics: Vaginitis

Drug Information available for: Amoxicillin Amoxicillin sodium

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

The proportion of participants with eradication of GV in each study arm at Visit 2 as assessed by NAAT. [ Time Frame: Day 15 to 21 ]

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. [ Time Frame: Day 15 to 21 ]


Estimated Enrollment:	98
Anticipated Study Start Date:	July 27, 2017
Estimated Study Completion Date:	June 4, 2018
Estimated Primary Completion Date:	June 4, 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo arm Placebo 2 capsules PO twice a day for 7 days, n=49	Other: Placebo Placebo
Experimental: Treatment arm Amoxicillin 2 x 250 mg capsules PO twice a day for 7 days, n=49	Drug: Amoxicillin Amoxicillin is an aminopenicillin antibiotic

Detailed Description:

This is a randomized, double-blind, placebo-controlled pilot 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 10 months and subject participation duration is approximately 15 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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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) (see Section 8)
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.
Use of antibiotics in the past 14 days prior to screening visit.
HIV infected.
Women taking immunosuppressive agents.
Diagnosis of BV within the prior 6 months.
History of recurrent BV (more than one episode of BV in the prior 12 months).
History of renal impairment.
Use of any investigational drug within the past 30 days prior to screening.
Any other condition that, in the opinion of the investigator, would interfere with participation in the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211156

Contacts


Contact: Jane Schwebke	12059345191	Schwebke@uab.edu

Locations


United States, Alabama
University of Alabama at Birmingham School of Medicine- Infectious Disease	Not yet recruiting
Birmingham, Alabama, United States, 35205
United States, North Carolina
Guilford County Health Department - Greensboro - STD Clinic	Not yet recruiting
Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information


Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT03211156 History of Changes
Other Study ID Numbers:	16-0073 HHSN272201300012I
Study First Received:	July 6, 2017
Last Updated:	July 6, 2017


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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):


Amoxicillin Gardnerella vaginalis Vaginal Colonization

Additional relevant MeSH terms:


Vaginitis Vaginosis, Bacterial Vaginal Diseases Genital Diseases, Female	Bacterial Infections Amoxicillin Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on July 11, 2017