Gatifloxacin versus ofloxacin for the treatment of uncomplicated enteric fever in Nepal: an open-label, randomized, controlled trial.
PLoS Negl Trop Dis
; 7(10): e2523, 2013.
Article
em En
| MEDLINE
| ID: mdl-24282626
ABSTRACT
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 PRINCIPALFINDINGS:
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, pâ=â0.73). 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 (HRâ=â1.59, 95% CI 1.16 to 2.18, pâ=â0.004). 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).
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Febre Tifoide
/
Ofloxacino
/
Fluoroquinolonas
/
Antibacterianos
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
/
Adult
/
Child
/
Female
/
Humans
/
Male
País como assunto:
Asia
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article