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]. 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
Data supporting a publication on the potential benefits of using gatifloxacin to treat Enteric (typhoid) fever, in comparison to cephalosporin ceftriaxone. Data is made available as supplementary material to accompany paper.
Keywords
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 |
|
||||||||
Date (Date published in a 3rd party system) | 20 January 2016 | ||||||||
Geographical area covered (offline during plugin upgrade) |
|
||||||||
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 |
Funders |
|
---|
Date Deposited | 01 Feb 2016 10:25 |
---|---|
Last Modified | 23 Mar 2021 15:08 |
Publisher | The Lancet Infectious Diseases |