Ciprofloxacin Multiple Dose for Adult Cholera

NCT00741052 | Completed Phase 3

• 1 other identifier: 2007-022
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cholera

Keywords

V. cholerae,; ciprofloxacin,; azithromycin,; randomized

Outcome Measures

Primary Outcomes (1)

• To determine whether clinical success of therapy in the two treatment regimens are comparable.

  48 hours

Secondary Outcomes (1)

• 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.

  48 hours

Study Arms (2)

1

EXPERIMENTAL

Ciprofloxacin

Drug: Ciprofloxacin

2

ACTIVE COMPARATOR

Azithromycin

Drug: Azithromycin

Interventions

Ciprofloxacin DRUG

12 hourly oral dose of ciprofloxacin for 3 days

Also known as: BEOFLOX

1

Azithromycin DRUG

1 gm Azithromycin single dose

Also known as: TRIDOSIL

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Cholera

Interventions

Ciprofloxacin; Azithromycin

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Wasif A Khan, MBBS, MS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 26, 2008
• Study Start: July 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: June 1, 2010
• Last Updated: July 12, 2011

Record last verified: 2008-08

Locations

BA (1)