COMPARATIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY OF RIFAXIMIN VS CYPROFLOXACIN (CIPRO®) IN THE TREATMENT OF DISEASE DIAPEREA CAUSED BY ENTEROPATHOGENIC ORGANISMS
Not Applicable
- Conditions
- -A04 Other bacterial intestinal infectionsOther bacterial intestinal infectionsA04
- Registration Number
- PER-055-02
- Lead Sponsor
- IVERSIDAD PERUANA CAYETANO HEREDIA,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients of male or female sex of 18 years of age or
greater.
A minimum of three stools not formed within 24 hours prior to randomization.
Acute diarrhea and presence of at least one of the signs or symptoms of enteric infection present for a period not exceeding 96 hours.
Exclusion Criteria
Acute diarrhea for more than 96 hours.
Moderate or severe dehydration.
Temperature <39.0 ° C (<102.2®F).
White blood cell count> 20,000 or bandemia> 20%
Presence of systemic toxicity that suggests a disease
bacteremic
Positive detection of E. histolytic trophozoites.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:using the time elapsed until the last stool deposition not formed<br>Measure:The main variable of effectiveness assessment will be the duration of diarrhea after the start of study therapy<br>Timepoints:24 hours<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:1. Improvement of pain / abdominal cramps and the urgent need to defecate<br>2. Eradication / microbiological failure<br>3. The number of stool stools not formed evacuated by time interval<br>4. Improvement of diarrheal syndrome<br>5. The number of subjects with clinical cure (improvement)<br>6. The number of days of hospitalization<br>7. The number of subjects who failed treatment<br>Measure:Secondary Variables of Efficacy Assessment<br>Timepoints:24 hours<br>