Ciprofloxacin Multiple Dose for Adult Cholera

This study has been completed.
Sponsor:
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00741052
First received: August 4, 2008
Last updated: July 11, 2011
Last verified: August 2008
  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 3

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

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • To determine whether clinical success of therapy in the two treatment regimens are comparable. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741052

Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Wasif A Khan, MBBS, MS International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

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

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
V. cholerae,
ciprofloxacin,
azithromycin,
randomized

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 20, 2014