Trial Outcomes & Findings for Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin (NCT NCT03211156)
NCT ID: NCT03211156
Last Updated: 2020-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Day 15 to 21
Results posted on
2020-08-28
Participant Flow
Participants were recruited from women who were colonized/infected with Gardnerella vaginalis but have no clinical evidence of Bacterial Vaginosis. Enrollment occurred between 21SEP2017 and 08AUG2019.
Participant milestones
| Measure |
Placebo
Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49
Placebo: Placebo
|
Amoxicillin
Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
Received Study Drug
|
47
|
45
|
|
Overall Study
COMPLETED
|
47
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49
Placebo: Placebo
|
Amoxicillin
Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Treatment of Gardnerella Vaginalis Vaginal Colonization With Amoxicillin
Baseline characteristics by cohort
| Measure |
Placebo
n=49 Participants
Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49
Placebo: Placebo
|
Amoxicillin
n=48 Participants
Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 7.8 • n=39 Participants
|
29.0 years
STANDARD_DEVIATION 7.3 • n=41 Participants
|
29.8 years
STANDARD_DEVIATION 7.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
97 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=39 Participants
|
44 Participants
n=41 Participants
|
90 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=39 Participants
|
29 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=39 Participants
|
48 participants
n=41 Participants
|
97 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Day 15 to 21Population: Participants included in the ITT population are those who randomized, regardless of whether they received study treatment or were compliant with the administration procedures or schedule.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49
Placebo: Placebo
|
Amoxicillin
n=48 Participants
Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
|
|---|---|---|
|
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).
|
0.16 proportion of participants
Interval 0.09 to 0.29
|
0.21 proportion of participants
Interval 0.12 to 0.34
|
SECONDARY outcome
Timeframe: Day 1 through Day 15 to 21Population: Participants included in the safety population are those who randomized and received at least one dose of treatment.
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.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49
Placebo: Placebo
|
Amoxicillin
n=45 Participants
Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
|
|---|---|---|
|
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.
|
0.04 proportion of participants
Interval 0.01 to 0.14
|
0.18 proportion of participants
Interval 0.08 to 0.32
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Amoxicillin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Participants received Amoxicillin placebo 2 capsules orally twice a day for 7 days, n=49
Placebo: Placebo
|
Amoxicillin
n=45 participants at risk
Participants received Amoxicillin 2 x 250 mg capsules orally twice a day for 7 days, n=48
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/47 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Immune system disorders
Allergic reaction to excipient
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.1%
1/47 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
4.4%
2/45 • Number of events 2 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Investigations
Potassium hydroxide preparation positive
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/47 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
0.00%
0/45 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/47 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
2.2%
1/45 • Number of events 1 • Unsolicited non-serious AEs and SAE were collected through Visit 2 (Day 15-21) after the first dose of treatment.
The safety data collection was targeted to collect serious and non-serious adverse events and congenital anomalies / birth defects as applicable that occurred after the first dose of treatment through Visit 2 (Day 15-21). Adverse events were captured by subject report/interview and clinical assessments, including clinician-conducted pelvic examination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60