Diarrhea
Conditions
Keywords
TD, traveller's diarrhea, campylobacter, shigella, salmonella, E. coli, diarrhea
Brief summary
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
Detailed description
To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
Interventions
DRUGRifaximin
DRUGPlacebo
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. travelling to Mexico within 72 hours of enrollment 2. read and understand English 3. in good health
Exclusion criteria
1. acute diarrhea within previous 7 days 2. taken FQs (any drug in this class), macrolide, azalide, or trimethoprim-sulfamethoxazole within 7 days or enrollment or anytime during study. 3. taken antidiarrheal medication within 24 hours of enrollment or anytime during study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment | 14 days | The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm 1 Rifaximin 600 MG QD | 106 |
| Placebo Arm Matching Placebo 600MG QD | 104 |
| Total | 210 |
Baseline characteristics
| Characteristic | Treatment Arm 1 | Placebo Arm | Total |
|---|---|---|---|
| Age, Continuous | 23.5 years STANDARD_DEVIATION 9.15 | 22.9 years STANDARD_DEVIATION 7.28 | 23.2 years STANDARD_DEVIATION 8.26 |
| Sex: Female, Male Female | 66 Participants | 70 Participants | 136 Participants |
| Sex: Female, Male Male | 40 Participants | 34 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 81 / 106 | 93 / 104 |
| serious Total, serious adverse events | 0 / 106 | 0 / 104 |
Outcome results
Primary
Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment
The efficacy of 14 days of rifaximin 600 mg once daily (QD) compared with placebo when taken by healthy subjects to prevent travelers' diarrhea (TD) resulting from all causes.
Time frame: 14 days
Population: The Intent to Treat (ITT) population received at least 1 dose of the study drug. For the ITT population, 99 participants were in the rifaximin group and 102 were in the placebo group. The EE consisted of105 of 106 subjects and the placebo group, 100 of 104 subjects were EE. All subject included in Safety analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment | 15 Participants |
| Placebo Arm | Cumulative Occurrence of Travellers' Diarrhea (TD) for Rifaximin 600 mg QD Compared to Placebo Over 14 Days of Treatment | 48 Participants |