METHODS

Design:

randomised controlled trial.

Allocation:

{concealed*}†.

Blinding:

blinded {patients, healthcare providers, data collectors, outcome assessors, data analysts, and monitoring committee}†.*

Follow up period:

48 hours (for primary outcome).

Setting:

a diarrhoea treatment centre in Dhaka, Bangladesh.

Patients:

198 men 18–60 years of age (median age 25 y) who had watery diarrhoea for ⩽24 hours, severe dehydration, a high purging rate (stool volume ⩾20 ml/kg body weight over a 4 hour period after initial rehydration), and isolation of Vibrio cholerae O1 or O139 from a stool or rectal swab sample. Exclusion criteria were concomitant illness or receipt of an antimicrobial agent effective for treatment of cholera.

Intervention:

azithromycin, two 500 mg tablets, plus a placebo formulation of ciprofloxacin …