Gatifloxacin Versus Ofloxacin for the Treatment of Uncomplicated Enteric Fever in Nepal: An Open-Label,Randomized,Controlled Trial

Background:fluoroquinolones are the most commonly used group of antimicrobials for the treatment of enteric fever,but no direct comparison between two fluoroquinolones has been performed in a large randomised trial. an open-label randomized trial was conducted to investigate whether gatifloxacin is more effective than ofloxacin in the treatment of uncomplicated enteric fever caused by nalidixic acid-resistant salmonella enterica serovars typhi and paratyphi a.methodology and principal findings:adults and children clinically diagnosed with uncomplicated enteric fever were enrolled in the study to receive gatifloxacin (10 mg/kg/day) in a single dose or ofloxacin (20 mg/kg/day) in two divided doses for 7 days. patients were followed for six months. the primary outcome was treatment failure in patients infected with nalidixic acid resistant isolates. 627 patients with a median age of 17 (iqr 9-23) years were randomised. of the 218 patients with culture confirmed enteric fever,170 patients were infected with nalidixic acid-resistant isolates. in the ofloxacin group,6 out of 83 patients had treatment failure compared to 5 out of 87 in the gatifloxacin group (hazard ratio [hr] of time to failure 0.81,95% ci 0.25 to 2.65,p = 0.73). the median time to fever clearance was 4.70 days (iqr 2.98-5.90) in the ofloxacin group versus 3.31 days (iqr 2.29-4.75) in the gatifloxacin group (hr = 1.59,95% ci 1.16 to 2.18,p = 0.004). the results in all blood culture-confirmed patients and all randomized patients were comparable.conclusion:gatifloxacin was not superior to ofloxacin in preventing failure,but use of gatifloxacin did result in more prompt fever clearance time compared to ofloxacin. trial registration: isrctn 63006567 (www.controlled-trials.com). © 2013 koirala et al.