Trial Outcomes & Findings for Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea (NCT NCT01208922)
NCT ID: NCT01208922
Last Updated: 2019-02-27
Results Overview
Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
835 participants
Primary outcome timeframe
5 days
Results posted on
2019-02-27
Participant Flow
Recruited from November 2010 until January 2016
A total of 835 patients were enrolled and were randomised to one of the 2 treatment groups according to the randomisation plan. All randomised patients received at least one dose of study medication.
Participant milestones
| Measure |
Rifamycin Group
Rifamycin SV-MMX® 200 mg tablets
Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
|
Ciprofloxacin Group
Ciprofloxacin 500 mg capsules
Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
|
|---|---|---|
|
Overall Study
STARTED
|
420
|
415
|
|
Overall Study
COMPLETED
|
409
|
405
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Baseline characteristics by cohort
| Measure |
Group A
n=420 Participants
Rifamycin SV-MMX® 200 mg tablets
Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
|
Group B
n=415 Participants
Ciprofloxacin 500 mg capsules
Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
|
Total
n=835 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 16.6 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
215 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
75 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
342 Participants
n=5 Participants
|
344 Participants
n=7 Participants
|
686 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Ecuador
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Guatemala
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
India
|
405 participants
n=5 Participants
|
400 participants
n=7 Participants
|
805 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Efficacy results were reported for Full Analysis Set, which all randomised patients (as randomised) who received at least one dose of study medication. Patients with uncertainty as to whether they had received study medication or not (e.g., due to lost to follow-up) were included.
Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.
Outcome measures
| Measure |
Group A
n=420 Participants
Rifamycin SV-MMX® 200 mg tablets
Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
|
Group B
n=415 Participants
Ciprofloxacin 500 mg capsules
Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
|
|---|---|---|
|
Time to Last Unformed Stool (TLUS)
|
44.3 hours
Interval 40.1 to 47.5
|
40.3 hours
Interval 33.5 to 44.8
|
SECONDARY outcome
Timeframe: 5 daysClinical Cure Rate: 24-hour period with no clinical symptoms except mild flatulence, no fever, no watery stools and no more than 2 soft stools OR 48-hour period with no stools or only formed stools, and no fever, with our without symptoms of enteric infection.
Outcome measures
| Measure |
Group A
n=420 Participants
Rifamycin SV-MMX® 200 mg tablets
Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
|
Group B
n=415 Participants
Ciprofloxacin 500 mg capsules
Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
|
|---|---|---|
|
Number of Patients With Clinical Cure
|
357 Participants
|
352 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=420 participants at risk
Rifamycin SV-MMX® 200 mg tablets
Rifamycin SV-MMX®: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
|
Group B
n=415 participants at risk
Ciprofloxacin 500 mg capsules
Ciprofloxacin: 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.1%
13/420 • Number of events 13 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
2.2%
9/415 • Number of events 9 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
8/420 • Number of events 8 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
1.4%
6/415 • Number of events 6 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
6/420 • Number of events 6 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
1.4%
6/415 • Number of events 6 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
|
Gastrointestinal disorders
Flatulence
|
1.2%
5/420 • Number of events 5 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
1.4%
6/415 • Number of events 6 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.95%
4/420 • Number of events 4 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
1.2%
5/415 • Number of events 5 • An average of 1 month
Non-serious AEs were analysed as Treatment-Emergent AEs defined as all AEs with onset after treatment day 1 but not after the last day with study drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place