EARLY SINGLE-DOSE THERAPY WITH OFLOXACIN FOR EMPIRICAL-TREATMENT OF ACUTE GASTROENTERITIS - A RANDOMIZED, PLACEBO-CONTROLLED DOUBLE-BLIND CLINICAL-TRIAL

This study is a double-blind, placebo-controlled, randomised clinical trial to evaluate the clinical and microbiological efficacy and safety of single dose ofloxacin for acute diarrhoea. Eligible patients were 16 years of age or older with a history of acute diarrhoea lasting no more than 48 h; 117 patients were randomised and 97.4% (114/117) were evaluable for efficacy. Of these, 58% were suspected to have ingested contaminated foods. Enteric pathogens were isolated in 61.5% of the pa tients, Salmonella enteritidis being reported in 87.5%. The patients r eceived either a single 400 mg dose of ofloxacin, or placebo. The aver age duration of diarrhoea was 2.56 +/- 2.21 days in the ofloxacin grou p and 3.41 +/- 25 in the placebo group (P = 0.117). The average durati on of fever was 0.63 +/- 0.95 days in the ofloxacin group and 1.05 +/- 0.96 in the placebo group (P = 0.02). Symptoms remained unchanged for more than 48 h in only 7% of the patients who received ofloxacin, com pared with 12% in the placebo group (P = 0.485). Only 32% of patients in the ofloxacin group remained culture positive after 48 h compared w ith 59% in the placebo group (P = 0.0018). These represent a relative risk reduction (RRR) for stool clearance of 45.5% and absolute risk re duction (ARR) of 27% (95% Cl, 8-44.7), with a number of patients neede d to treat (NNT) of 3.7 (95%, 27-11.3). After 15 days, 23.3% of patien ts in the ofloxacin group had a positive culture compared with 28.9% i n the placebo (P = 0.63). This represents an RRR of 19%, an ARR of 5.6 % and a NNT of 17.8. Adverse events in the ofloxacin group were observ ed in only one patient who reported headache and in one patient in the placebo group who developed a rash. In summary, empirical treatment w ith a single dose of ofloxacin in acute diarrhoea did not reduce the i ntensity or duration of symptoms (except possibly length of fever). It was notable however that stool cultures became negative for S. enteri tidis by 48 h, with no relapse after 2 weeks of follow-up.