Ciprofloxacin Multiple Dose for Adult Cholera
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|ClinicalTrials.gov Identifier: NCT00741052|
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : July 12, 2011
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 or disease||Intervention/treatment||Phase|
|Cholera||Drug: Ciprofloxacin Drug: Azithromycin||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||June 2010|
12 hourly oral dose of ciprofloxacin for 3 days
Other Name: BEOFLOX
Active Comparator: 2
1 gm Azithromycin single dose
Other Name: TRIDOSIL
- To determine whether clinical success of therapy in the two treatment regimens are comparable. [ Time Frame: 48 hours ]
- Compare the rates of bacteriological success. Compare the diarrhea duration. Compare stool volume of patients. Measure stool concentrations of the two drugs and compare them with MICs of V. cholerae. Record and compare adverse events. [ Time Frame: 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741052
|Dhaka, Bangladesh, 1212|
|Principal Investigator:||Wasif A Khan, MBBS, MS||International Centre for Diarrhoeal Disease Research, Bangladesh|