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COMPARATIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY OF RIFAXIMIN VS CYPROFLOXACIN (CIPRO®) IN THE TREATMENT OF DISEASE DIAPEREA CAUSED BY ENTEROPATHOGENIC ORGANISMS

COMPARATIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY OF RIFAXIMIN VS CYPROFLOXACIN (CIPRO®) IN THE TREATMENT OF DISEASE DIAPEREA CAUSED BY ENTEROPATHOGENIC ORGANISMS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-055-02
Enrollment
Unknown
Registered
2002-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

RIFAXIMINE Type of group
One capsule containing a 200 mg tablet of rifaximin. You will be given two capsules, which will be taken orally, three times a day for 5 consecutive days. Group name:CIPROFLOXACINE Type of group
Ciprofloxacin, (2) capsules of 250 mg of ciprofloxacin each, for its taking in the morning and at night, plus an additional daily dose of (2) equal capsules of placebo, for 5 days.

Sponsors

UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Acute diarrhea for more than 96 hours. Moderate or severe dehydration. Temperature 20,000 or bandemia> 20% Presence of systemic toxicity that suggests a disease bacteremic Positive detection of E. histolytic trophozoites.

Design outcomes

Primary

MeasureTime frame
Outcome name:using the time elapsed until the last stool deposition not formed Measure:The main variable of effectiveness assessment will be the duration of diarrhea after the start of study therapy Timepoints:24 hours

Secondary

MeasureTime frame
Outcome name:1. Improvement of pain / abdominal cramps and the urgent need to defecate 2. Eradication / microbiological failure 3. The number of stool stools not formed evacuated by time interval 4. Improvement of diarrheal syndrome 5. The number of subjects with clinical cure (improvement) 6. The number of days of hospitalization 7. The number of subjects who failed treatment Measure:Secondary Variables of Efficacy Assessment Timepoints:24 hours

Countries

Mexico, Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)