Early single dose therapy with ofloxacin for empirical treatment of acute gastroenteritis: a randomised, placebo-controlled double-blind clinical trial

Abstract

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 patients, Salmonella enteritidis being reported in 87.5%. The patients received either a single 400 mg dose of ofloxacin, or placebo. The average duration of diarrhoea was 2.56 +/- 2.21 days in the ofloxacin group and 3.41 +/- 2.5 in the placebo group (P = 0.117). The average duration 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, compared with 12% in the placebo group (P = 0.485). Only 32% of patients in the ofloxacin group remained culture positive after 48 h compared with 59% in the placebo group (P = 0.0018). These represent a relative risk reduction (RRR) for stool clearance of 45.5% and absolute risk reduction (ARR) of 27% (95% Cl, 8-44.7), with a number of patients needed to treat (NNT) of 3.7 (95%, 2.7-11.3). After 15 days, 23.3% of patients in the ofloxacin group had a positive culture compared with 28.9% in 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 observed in only one patient who reported headache and in one patient in the placebo group who developed a rash. In summary, empirical treatment with a single dose of ofloxacin in acute diarrhoea did not reduce the intensity or duration of symptoms (except possibly length of fever). It was notable however that stool cultures became negative for S. enteritidis by 48 h, with no relapse after 2 weeks of follow-up.

The Practice of Travel Medicine: Guidelines by the Infectious Diseases Society of America

“…Although many clinical trials have studied 3 or more days of therapy with an antibiotic for the treatment of traveler's diarrhea, a single dose has been shown to be effective [16,238], and in several head-to-head comparisons, has been shown to have equivalent efficacy to a 3-day course of antibiotics [15,191,192,222,239]. Concern has been raised, however, that severe diarrhea might be better treated with 3 days of therapy than with a single dose.…”

Infectious disease: diarrhea

“…We found 9 randomized controlled trials in 8 reports [20][21][22][23][24][25][26][27] (1,760 participants) 21 Entry criteria varied between trials, and treatment duration ranged from a single dose to 5 days. In 3 trials, antibiotics reduced illness duration 24,27 or decreased the number of liquid stools by 48 hours, 20 whereas in 5, illness duration was not reduced.…”

“…In 3 trials, antibiotics reduced illness duration 24,27 or decreased the number of liquid stools by 48 hours, 20 whereas in 5, illness duration was not reduced. [21][22][23]26 In 1 trial, the illness duration after ciprofloxacin was reduced but not after trimethoprim-sulfamethoxazole.…”

Infectious Disease Issues in the Emergency Department

“…Fluoroquinolones have been demonstrated to significantly shorten the duration of illness of patients with acute domestically acquired diarrhea (by 1-3 days) in some trials, regardless ofthe presence of fecal leukocytes, culture-positivity for enteric pathogens, or severity of disease [78][79][80]. These results may reflect the inadequate predictive value of the stool leukocyte test as well as the lack of sensitivity of stool cultures.…”