Status:
COMPLETED
Single Dose Azithromycin in the Treatment of Adult Cholera
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Pfizer
Tufts Medical Center
Conditions:
Cholera
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Cholera remains an important cause of diarrhoeal illness and death in Asia, Africa and Latin America. Antimicrobial therapy is an important adjunct to fluid therapy in the management of patients with ...
Detailed Description
A total of 182 evaluable patients (those with a positive stool culture for V. cholerae O1 or V. cholerae O139 and remain in the study for full 5 days) will be required for this study. Patients who me...
Eligibility Criteria
Inclusion
- Age: 18 - 60 years
- Gender: Male (To facilitate accurate measurement of stool and urine, and also due to the difficulties in hospitalizing women for longer duration)
- Duration of illness: 24 hours or less
- Written informed consent for participation in the study
- Dehydration status: Signs of severe dehydration as determined by World Health Organization criteria.
- Positive stool dark-field microscopic examination for V. cholerae, and subsequent isolation of V. cholerae O1 or O139 from an admission culture of a stool or rectal swab sample.
Exclusion
- History of receiving even one dose of an antimicrobial agent effective in the treatment of cholera, and even a single fose of the drugs under evaluation.
- Concomitant infection requiring antimicrobial therapy other than the study drugs which may interfere with evaluation of either the efficacy or safety of the study drugs.
- A concomitant illness which may confound evaluation of outcome or is a contraindication for use of either of the study drugs (chronic heart, lung, of kidney disease, or instance), or conditions which may confound evaluation of adverse events of the study drugs.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00229944
Start Date
December 1 2002
End Date
May 1 2004
Last Update
July 21 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dhaka Hospital, International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212