Abstract
ObjectiveTo assess the efficacy of gatifloxacin versus cefixime in the treatment of uncomplicated culture positive enteric fever.DesignA randomized, open-label, active control trial with two parallel arms.SettingEmergency Room and Outpatient Clinics in Patan Hospital, Lagankhel, Lalitpur, Nepal.ParticipantsPatients with clinically diagnosed uncomplicated enteric fever meeting the inclusion criteria.InterventionsPatients were allocated to receive one of two drugs, Gatifloxacin or Cefixime. The dosages used were Gatifloxacin 10 mg/kg, given once daily for 7 days, or Cefixime 20 mg/kg/day given in two divided doses for 7 days.Outcome MeasuresThe primary outcome measure was fever clearance time. The secondary outcome measure was overall treatment failure (acute treatment failure and relapse).ResultsRandomization was carried out in 390 patients before enrollment was suspended on the advice of the independent data safety monitoring board due to significant differences in both primary and secondary outcome measures in the two arms and the attainment of a priori defined endpoints. Median (95% confidence interval) fever clearance times were 92 hours (84–114 hours) for gatifloxacin recipients and 138 hours (105–164 hours) for cefixime-treated patients (Hazard Ratio[95%CI] = 2.171 [1.545–3.051], p<0.0001). 19 out of 70 (27%) patients who completed the 7 day trial had acute clinical failure in the cefixime group as compared to 1 out of 88 patients (1%) in gatifloxacin group(Odds Ratio [95%CI] = 0.031 [0.004 – 0.237], p<0.001). Overall treatment failure patients (relapsed patients plus acute treatment failure patients plus death) numbered 29. They were determined to be (95% confidence interval) 37.6 % (27.14%–50.2%) in the cefixime group and 3.5% (2.2%–11.5%) in the gatifloxacin group (HR[95%CI] = 0.084 [0.025–0.280], p<0.0001). There was one death in the cefixime group.ConclusionsBased on this study, gatifloxacin is a better treatment for uncomplicated enteric fever as compared to cefixime.Trial RegistrationCurrent Controlled Trials ISRCTN75784880
Highlights
Enteric fever (Typhoid and Paratyphoid fever) is a systemic infection caused by the bacterium Salmonella enterica serovar Typhi (S.typhi) or Salmonella enterica serovar Paratyphi (S. paratyphi) which in humans is transmitted through the fecal-oral route [1,2]
We enrolled patients who presented to the outpatient or emergency department of Patan Hospital, Lalitpur, Nepal from June 5, 2005 to September 8, 2005
Of the 482 patients from the study area who were clinically diagnosed with enteric fever, 390 patients were enrolled into the study and randomized. 92 patients were ineligible, the main reason (49 patients) being a history of already having taken antibiotics within one week prior to study entry (Figure 1)
Summary
Enteric fever (Typhoid and Paratyphoid fever) is a systemic infection caused by the bacterium Salmonella enterica serovar Typhi (S.typhi) or Salmonella enterica serovar Paratyphi (S. paratyphi) which in humans is transmitted through the fecal-oral route [1,2]. The best global estimates are of at least 22 million cases of typhoid fever each year with 200,000 deaths [3] These are almost exclusively confined to resource poor countries. Gatifloxacin, a relatively inexpensive fluoroquinolone antibiotic in South Asia with once daily oral administration, is a new broad spectrum synthetic 8-methoxyfluoroquinolone which has the lowest minimum inhibitory concentration (MIC) against S. typhi from Nepal [9]. This in vitro activity needs to be verified clinically before gatifloxacin can be recommended for widespread use. Cefixime is recommended as a drug of choice by the
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