Status:
COMPLETED
Ciprofloxacin Multiple Dose for Adult Cholera
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Cholera
Eligibility:
MALE
18-60 years
Phase:
PHASE3
Brief Summary
Cholera is an important diarrhoeal disease and an important cause of death, particularly during epidemic outbreaks, in Bangladesh and many other developing countries. Used as an adjunct to management ...
Detailed Description
Cholera is caused by infection of the human intestine with Vibrio cholerae O1 or V. cholerae O139. It is a major health problem in many developing countries including Bangladesh.1 The importance of ch...
Eligibility Criteria
Inclusion
- Age: 18 - 60 years.
- Gender: Male
- Duration of diarrhoea: Not exceeding 24 hours
- Written informed consent for participation.
- Dehydration status: Severe dehydration.
- Positive stool dark-field microscopic examination for V. cholerae \& culture positive for V cholerae
- For patients assigned to receive ciprofloxacin, an MIC of the V. cholerae isolates to ciprofloxacin of \> 0.190 µg/ml and to azithromycin of ≤ 0.125 µg/ml.
Exclusion
- History of receiving an antimicrobial agent known to be effective in cholera in adults.
- Concomitant infection requiring antimicrobial therapy other than the study drugs.
- Chronic illness.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00741052
Start Date
July 1 2007
End Date
June 1 2010
Last Update
July 12 2011
Active Locations (1)
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1
ICDDR,B
Dhaka, Bangladesh, 1212