Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial

Arjyal, A; Basnyat, B; Nhan, HT; Koirala, S; Giri, A; Joshi, N; Shakya, M; Pathak, KR; Mahat, SP; Prajapati, SP; Adhikari, N; Thapa, R; Merson, L; Gajurel, D; Lamsal, K; Lamsal, D; Yadav, BK; Shah, G; Shrestha, P; Dongol, S; Karkey, A; Thompson, C; Thieu, NTV; Thanh, DP; Baker, S; Thwaites, GE; Wolbers, M and Dolecek, C (2016). Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial. [Dataset]. The Lancet Infectious Diseases, London, United Kingdom. 10.1016/S1473-3099(15)00530-7.
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Data supporting a publication on the potential benefits of using gatifloxacin to treat Enteric (typhoid) fever, in comparison to cephalosporin ceftriaxone.

Keywords

Enteric fever; Typhoid; Cephalosporin ceftriaxone

Item Type Dataset
Resource Type
Resource Type
Resource Description
Dataset
UNSPECIFIED
Description of data capture We did an open-label, randomised, controlled, superiority trial at two hospitals in the Kathmandu valley, Nepal. Eligible participants were children (aged 2–13 years) and adult (aged 14–45 years) with criteria for suspected enteric fever (body temperature ≥38·0°C for ≥4 days without a focus of infection). We randomly assigned eligible patients (1:1) without stratification to 7 days of either oral gatifloxacin (10 mg/kg per day) or intravenous ceftriaxone (60 mg/kg up to 2 g per day for patients aged 2–13 years, or 2 g per day for patients aged ≥14 years). The randomisation list was computer-generated using blocks of four and six. The primary outcome was a composite of treatment failure, defined as the occurrence of at least one of the following: fever clearance time of more than 7 days after treatment initiation; the need for rescue treatment on day 8; microbiological failure (ie, blood cultures positive for Salmonella enterica serotype Typhi, or Paratyphi A, B, or C) on day 8; or relapse or disease-related complications within 28 days of treatment initiation. We did the analyses in the modified intention-to-treat population, and subpopulations with either confirmed blood-culture positivity, or blood-culture negativity. The trial was powered to detect an increase of 20% in the risk of failure. This trial was registered at ClinicalTrials.gov, number NCT01421693, and is now closed.
Capture method Experiment
Collection Period
From
To
18 September 2011
14 July 2014
Date 20 January 2016
Geographical area covered (offline during plugin upgrade)
North Latitude
East Longitude
South Latitude
West Longitude
28.1722
85.9103
27.214
84.8447
Language(s) of written materials English
Creator(s) Arjyal, A; Basnyat, B; Nhan, HT; Koirala, S; Giri, A; Joshi, N; Shakya, M; Pathak, KR; Mahat, SP; Prajapati, SP; Adhikari, N; Thapa, R; Merson, L; Gajurel, D; Lamsal, K; Lamsal, D; Yadav, BK; Shah, G; Shrestha, P; Dongol, S; Karkey, A; Thompson, C; Thieu, NTV; Thanh, DP; Baker, S; Thwaites, GE; Wolbers, M and Dolecek, C
LSHTM Faculty/Department Faculty of Infectious and Tropical Diseases > Dept of Pathogen Molecular Biology (-2019)
Participating Institutions London School of Hygiene & Tropical Medicine
Funders
Project
Funder
Grant Number
Funder URI
UNSPECIFIED
Wellcome Trust
UNSPECIFIED
UNSPECIFIED
UNSPECIFIED
Li Ka Shing Foundation
UNSPECIFIED
UNSPECIFIED
Date Deposited 01 Feb 2016 10:25
Last Modified 28 Sep 2018 21:18
Publisher The Lancet Infectious Diseases

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Data / Code

table1.csv
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Data
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Baseline characteristics of the modified intention-to-treat population
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table2.csv
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Minimum inhibitory concentration of organism in the culture-confirmed population at enrolment
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table3.csv
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Treatment failure (primary endpoint) overall and in predefined subgroups
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table4.csv
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Fever clearance time (secondary endpoint) overall and in predefined subgroups
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Time to treatment failure and fever clearance time
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Documentation

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Trial Profile
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