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.
Phase:
Phase 3
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh