The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
835
2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Site 401
Quito, Ecuador
Site 200
Quetzaltenango, Guatemala
Site 101
Mapusa, Karaswada, India
Time to Last Unformed Stool (TLUS)
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.
Time frame: 5 days
Number of Patients With Clinical Cure
Clinical 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.
Time frame: 5 days
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Site 124
Ajmer, India
Site 118
Bardez, India
Site 120
Calangute, India
Site 104
Hyderabad, India
Site 114
Kolkata, India
Site 116
Lucknow, India
Site 107
Madgaon, India
...and 9 more locations