Trial Outcomes & Findings for Efficacy of Rifaximin in Preventing Campylobacteriosis (NCT NCT02280044)
NCT ID: NCT02280044
Last Updated: 2018-11-20
Results Overview
A clinical illness meeting at least one of the following patterns: * Moderate to severe diarrhea. * Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or gross blood in ≥ 2 stools); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
30 participants
Primary outcome timeframe
120 hours after challenge
Results posted on
2018-11-20
Participant Flow
Per protocol, a total of thirty subjects were admitted to the inpatient unit and randomized to receive investigational product on day -1 to ensure the target sample size was obtained. Two subjects received three doses of product but were discharged on Day 0 prior to challenge. Both subjects were randomized to the placebo arm.
Participant milestones
| Measure |
Rifaximin
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
|
Placebo
Subjects receiving placebo will be challenged with C. jejuni
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Rifaximin
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
|
Placebo
Subjects receiving placebo will be challenged with C. jejuni
|
|---|---|---|
|
Overall Study
Planned alternate
|
0
|
2
|
Baseline Characteristics
Efficacy of Rifaximin in Preventing Campylobacteriosis
Baseline characteristics by cohort
| Measure |
Rifaximin
n=15 Participants
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
|
Placebo
n=15 Participants
Subjects receiving placebo will be challenged with C. jejuni
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
31 years
n=7 Participants
|
31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 hours after challengeA clinical illness meeting at least one of the following patterns: * Moderate to severe diarrhea. * Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or gross blood in ≥ 2 stools); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms.
Outcome measures
| Measure |
Rifaximin
n=15 Participants
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
|
Placebo
n=13 Participants
Subjects receiving placebo will be challenged with C. jejuni
|
|---|---|---|
|
Campylobacteriosis
|
13 Participants
|
11 Participants
|
POST_HOC outcome
Timeframe: 84 DaysRecovered C jejuni from fecal specimen on follow-up after an apparent cure
Outcome measures
| Measure |
Rifaximin
n=15 Participants
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
|
Placebo
n=13 Participants
Subjects receiving placebo will be challenged with C. jejuni
|
|---|---|---|
|
Recrudescent Events
|
2 Participants
|
3 Participants
|
Adverse Events
Rifaximin
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rifaximin
n=15 participants at risk
Subjects receiving rifaximin prophylaxis will be challenged with C. jejuni
|
Placebo
n=13 participants at risk
Subjects receiving placebo will be challenged with C. jejuni
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 6 • 84 days
|
69.2%
9/13 • Number of events 9 • 84 days
|
|
Gastrointestinal disorders
Abdominal Cramps
|
60.0%
9/15 • Number of events 9 • 84 days
|
69.2%
9/13 • Number of events 9 • 84 days
|
|
Gastrointestinal disorders
Abdominal pain
|
46.7%
7/15 • Number of events 7 • 84 days
|
53.8%
7/13 • Number of events 7 • 84 days
|
|
Gastrointestinal disorders
anorexia
|
60.0%
9/15 • Number of events 9 • 84 days
|
61.5%
8/13 • Number of events 8 • 84 days
|
|
Skin and subcutaneous tissue disorders
Bilateral knees and elbows itching
|
6.7%
1/15 • Number of events 1 • 84 days
|
0.00%
0/13 • 84 days
|
|
Gastrointestinal disorders
Bloating
|
20.0%
3/15 • Number of events 3 • 84 days
|
53.8%
7/13 • Number of events 7 • 84 days
|
|
Gastrointestinal disorders
Diarrhea (outpatient)
|
13.3%
2/15 • Number of events 2 • 84 days
|
23.1%
3/13 • Number of events 3 • 84 days
|
|
Gastrointestinal disorders
Dysentery
|
26.7%
4/15 • Number of events 4 • 84 days
|
61.5%
8/13 • Number of events 8 • 84 days
|
|
Skin and subcutaneous tissue disorders
Erythematous maculopapular rash
|
6.7%
1/15 • Number of events 1 • 84 days
|
0.00%
0/13 • 84 days
|
|
Gastrointestinal disorders
Gas
|
6.7%
1/15 • Number of events 1 • 84 days
|
23.1%
3/13 • Number of events 3 • 84 days
|
|
Reproductive system and breast disorders
Vaginal Yeast infection
|
0.00%
0/15 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
Gastrointestinal disorders
Abdominal tenderness
|
20.0%
3/15 • Number of events 3 • 84 days
|
30.8%
4/13 • Number of events 4 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
5/15 • Number of events 5 • 84 days
|
30.8%
4/13 • Number of events 4 • 84 days
|
|
Eye disorders
Blurred vision in right eye
|
6.7%
1/15 • Number of events 1 • 84 days
|
0.00%
0/13 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
0.00%
0/15 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
Gastrointestinal disorders
Bowel sounds
|
20.0%
3/15 • Number of events 3 • 84 days
|
15.4%
2/13 • Number of events 2 • 84 days
|
|
Gastrointestinal disorders
Campylobacter infection of recrudescence
|
13.3%
2/15 • Number of events 2 • 84 days
|
23.1%
3/13 • Number of events 3 • 84 days
|
|
Gastrointestinal disorders
Campylobacter infection of recrudescence 2
|
0.00%
0/15 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
Immune system disorders
Chills
|
66.7%
10/15 • Number of events 10 • 84 days
|
61.5%
8/13 • Number of events 8 • 84 days
|
|
Gastrointestinal disorders
Fecal Urgency
|
0.00%
0/15 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
Immune system disorders
Fever
|
53.3%
8/15 • Number of events 8 • 84 days
|
46.2%
6/13 • Number of events 6 • 84 days
|
|
Gastrointestinal disorders
Gastric bubbling
|
13.3%
2/15 • Number of events 2 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
General disorders
Headache
|
60.0%
9/15 • Number of events 9 • 84 days
|
69.2%
9/13 • Number of events 9 • 84 days
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
General disorders
Lightheadedness
|
33.3%
5/15 • Number of events 5 • 84 days
|
38.5%
5/13 • Number of events 5 • 84 days
|
|
General disorders
Malaise
|
66.7%
10/15 • Number of events 10 • 84 days
|
61.5%
8/13 • Number of events 8 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/15 • 84 days
|
15.4%
2/13 • Number of events 2 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.3%
8/15 • Number of events 8 • 84 days
|
38.5%
5/13 • Number of events 5 • 84 days
|
|
Gastrointestinal disorders
Pain with Defecation
|
0.00%
0/15 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
Skin and subcutaneous tissue disorders
Skin warm to touch
|
0.00%
0/15 • 84 days
|
7.7%
1/13 • 84 days
|
|
Musculoskeletal and connective tissue disorders
Swollen tender left wrist
|
0.00%
0/15 • 84 days
|
7.7%
1/13 • Number of events 1 • 84 days
|
|
Cardiac disorders
Tachycardia
|
33.3%
5/15 • Number of events 5 • 84 days
|
30.8%
4/13 • Number of events 4 • 84 days
|
|
Gastrointestinal disorders
Tenesmus
|
6.7%
1/15 • Number of events 1 • 84 days
|
15.4%
2/13 • Number of events 2 • 84 days
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 3 • 84 days
|
0.00%
0/13 • 84 days
|
Additional Information
David A Sack
Johns Hopkins Bloomberg School of Public Health
Phone: 443 287 8795
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place