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| Sponsor: | International Centre for Diarrhoeal Disease Research, Bangladesh |
|---|---|
| Information provided by: | International Centre for Diarrhoeal Disease Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00741052 |
Purpose
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 of dehydration, antimicrobial therapy using an appropriate agent reduces diarrhoea duration and stool volume in severe cholera by about half.
The usefulness of antimicrobials has, however, been greatly eroded by the increasing prevalence of resistant strains of V. cholerae O1. From October 2004 at the Matlab Hospital and from December 2004 at the Dhaka Hospital of ICDDR, B, V. cholerae strains became increasingly resistant to tetracycline and erythromycin- two drugs used in the treatment of severe cholera in adults and children respectively. Because of this high prevalence of resistance we resorted in early 2005 to using ciprofloxacin for treatment against multi drug resistant V. cholerae. Although all isolates were susceptible to ciprofloxacin when standard thresholds for disc-diffusion or E-test were used, but majority of the strains demonstrated a MIC value of 0.250 µg/ml, over hundred-folds greater than the V. cholerae strains tested in earlier years, which generally had a MIC of <0.003 µg/ml.
In this randomized, double blind, controlled trial we will assess clinical and bacteriological response to 12 hourly oral dose of ciprofloxacin for 3 days in which the first two doses will be 1 g each and the later 4 doses will be 500 mg each, and compare them with a single 1 g oral dose of azithromycin. We are using azithromycin as the comparator drug because current circulating V. cholerae isolates are susceptible (MIC ≤ 0.125 µg/ml) to this azithromycin, and single-dose azithromycin has been evaluated earlier to be effective in the treatment of cholera.
| Condition | Intervention | Phase |
|---|---|---|
|
Cholera |
Drug: Ciprofloxacin Drug: Azithromycin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double Blind, Controlled Clinical Trial to Evaluate the Efficacy of Multiple-dose Ciprofloxacin With Single Dose Azithromycin Therapy for Adults With Cholera Due to Multiply Resistant Strains of V. Cholerae O1 or O139 |
| Estimated Enrollment: | 218 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Ciprofloxacin
|
Drug: Ciprofloxacin
12 hourly oral dose of ciprofloxacin for 3 days
Other Name: BEOFLOX
|
|
Active Comparator: 2
Azithromycin
|
Drug: Azithromycin
1 gm Azithromycin single dose
Other Name: TRIDOSIL
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Bangladesh | |
| ICDDR,B | |
| Dhaka, Bangladesh, 1212 | |
| Principal Investigator: | Wasif A Khan, MBBS, MS | International Centre for Diarrhoeal Disease Research, Bangladesh |
More Information
| Responsible Party: | Principal Investigator, International Centre for Diarrhoeal Diseases Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00741052 History of Changes |
| Other Study ID Numbers: | 2007-022 |
| Study First Received: | August 4, 2008 |
| Last Updated: | July 11, 2011 |
| Health Authority: | Bangladesh: Ethical Review Committee |
|
V. cholerae, ciprofloxacin, azithromycin, randomized |
|
Cholera Vibrio Infections Gram-Negative Bacterial Infections Bacterial Infections Ciprofloxacin Azithromycin Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Anti-Bacterial Agents |