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. [Online]. The Lancet Infectious Diseases. Available from: https://doi.org/10.1016/S1473-3099(15)00530-7

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. Gatifloxacin versus ceftriaxone for uncomplicated enteric fever in Nepal: an open-label, two-centre, randomised controlled trial. [Internet] LSHTM Data Compass. The Lancet Infectious Diseases; 2016. Available from: https://doi.org/10.1016/S1473-3099(15)00530-7

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. [Data Collection]. The Lancet Infectious Diseases. https://doi.org/10.1016/S1473-3099(15)00530-7

Description

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.
Data capture method Experiment
Data Collection Period
FromTo
18 September 201114 July 2014
Date (Published in a 3rd party system) 20 January 2016
Geographical area covered
North LatitudeEast LongitudeSouth LatitudeWest Longitude
28.172285.910327.21484.8447
Language(s) of written materials English
Data Creators 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
Participating Institutions London School of Hygiene & Tropical Medicine, London, United Kingdom
Depositor Gareth Knight
Date Deposited 01 Feb 2016 10:25
Last Modified 17 Jan 2019 22:48
Publisher The Lancet Infectious Diseases

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