The NICE-GUT trial protocol

A randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children

Claire S. Waddington, Charlie Mcleod, Peter Morris, Asha Bowen, Mark Naunton, Jonathan Carapetis, Keith Grimwood, Roy Robins-Browne, Carl D. Kirkwood, Robert Baird, David Green, Ross Andrews, Deborah Fearon, Joshua Francis, Julie A. Marsh, Thomas Snelling

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction Diarrhoeal disease is the second leading cause of death in children under 5 years globally, killing 525 000 annually. Australian Aboriginal and Torres Strait Islander (hereafter Aboriginal) children suffer a high burden of disease. Randomised trials in other populations suggest nitazoxanide accelerates recovery for children with Giardia, amoebiasis, Cryptosporidium, Rotavirus and Norovirus gastroenteritis, as well as in cases where no enteropathogens are found. Methods and analysis This double blind, 1:1 randomised, placebo controlled trial is investigating the impact of oral nitazoxanide on acute gastroenteritis in hospitalised Australian Aboriginal children aged 3 months to <5 years. Dosing is based on age-based dosing. The primary endpoint is the time to resolution of€significant illness' defined as the time from randomisation to the time of clinical assessment as medically ready for discharge, or to the time of actual discharge from hospital, whichever occurs first. Secondary endpoints include duration of hospitalisation, symptom severity during the period of significant illness and following treatment, duration of rehydration and drug safety. Patients will be followed for medically significant events for 60 days. Analysis is based on Bayesian inference. Subgroup analysis will occur by pathogen type (bacteria, virus or parasite), rotavirus vaccination status, age and illness severity. Ethics and dissemination Ethics approval has been granted by the Central Australian Human Research Ethics Committee (HREC-14-221) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC2014-2172). Study investigators will ensure that the trial is conducted in accordance with the principles of the Declaration of Helsinki. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication.

Original languageEnglish
Article numbere019632
Pages (from-to)1-8
Number of pages8
JournalBMJ Open
Volume8
Issue number2
DOIs
Publication statusPublished - 1 Feb 2018

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nitazoxanide
Gastroenteritis
Clinical Protocols
Randomized Controlled Trials
Placebos
Rotavirus
Research Ethics Committees
Ethics
Helsinki Declaration
Northern Territory
Norovirus
Giardia
Amebiasis
Cryptosporidium
School Health Services
Fluid Therapy
Therapeutics
Random Allocation
Publications
Cause of Death

Cite this

Waddington, Claire S. ; Mcleod, Charlie ; Morris, Peter ; Bowen, Asha ; Naunton, Mark ; Carapetis, Jonathan ; Grimwood, Keith ; Robins-Browne, Roy ; Kirkwood, Carl D. ; Baird, Robert ; Green, David ; Andrews, Ross ; Fearon, Deborah ; Francis, Joshua ; Marsh, Julie A. ; Snelling, Thomas. / The NICE-GUT trial protocol : A randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children. In: BMJ Open. 2018 ; Vol. 8, No. 2. pp. 1-8.
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abstract = "Introduction Diarrhoeal disease is the second leading cause of death in children under 5 years globally, killing 525 000 annually. Australian Aboriginal and Torres Strait Islander (hereafter Aboriginal) children suffer a high burden of disease. Randomised trials in other populations suggest nitazoxanide accelerates recovery for children with Giardia, amoebiasis, Cryptosporidium, Rotavirus and Norovirus gastroenteritis, as well as in cases where no enteropathogens are found. Methods and analysis This double blind, 1:1 randomised, placebo controlled trial is investigating the impact of oral nitazoxanide on acute gastroenteritis in hospitalised Australian Aboriginal children aged 3 months to <5 years. Dosing is based on age-based dosing. The primary endpoint is the time to resolution of€significant illness' defined as the time from randomisation to the time of clinical assessment as medically ready for discharge, or to the time of actual discharge from hospital, whichever occurs first. Secondary endpoints include duration of hospitalisation, symptom severity during the period of significant illness and following treatment, duration of rehydration and drug safety. Patients will be followed for medically significant events for 60 days. Analysis is based on Bayesian inference. Subgroup analysis will occur by pathogen type (bacteria, virus or parasite), rotavirus vaccination status, age and illness severity. Ethics and dissemination Ethics approval has been granted by the Central Australian Human Research Ethics Committee (HREC-14-221) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC2014-2172). Study investigators will ensure that the trial is conducted in accordance with the principles of the Declaration of Helsinki. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication.",
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Waddington, CS, Mcleod, C, Morris, P, Bowen, A, Naunton, M, Carapetis, J, Grimwood, K, Robins-Browne, R, Kirkwood, CD, Baird, R, Green, D, Andrews, R, Fearon, D, Francis, J, Marsh, JA & Snelling, T 2018, 'The NICE-GUT trial protocol: A randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children', BMJ Open, vol. 8, no. 2, e019632, pp. 1-8. https://doi.org/10.1136/bmjopen-2017-019632

The NICE-GUT trial protocol : A randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children. / Waddington, Claire S.; Mcleod, Charlie; Morris, Peter; Bowen, Asha; Naunton, Mark; Carapetis, Jonathan; Grimwood, Keith; Robins-Browne, Roy; Kirkwood, Carl D.; Baird, Robert; Green, David; Andrews, Ross; Fearon, Deborah; Francis, Joshua; Marsh, Julie A.; Snelling, Thomas.

In: BMJ Open, Vol. 8, No. 2, e019632, 01.02.2018, p. 1-8.

Research output: Contribution to journalArticle

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T1 - The NICE-GUT trial protocol

T2 - A randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children

AU - Waddington, Claire S.

AU - Mcleod, Charlie

AU - Morris, Peter

AU - Bowen, Asha

AU - Naunton, Mark

AU - Carapetis, Jonathan

AU - Grimwood, Keith

AU - Robins-Browne, Roy

AU - Kirkwood, Carl D.

AU - Baird, Robert

AU - Green, David

AU - Andrews, Ross

AU - Fearon, Deborah

AU - Francis, Joshua

AU - Marsh, Julie A.

AU - Snelling, Thomas

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N2 - Introduction Diarrhoeal disease is the second leading cause of death in children under 5 years globally, killing 525 000 annually. Australian Aboriginal and Torres Strait Islander (hereafter Aboriginal) children suffer a high burden of disease. Randomised trials in other populations suggest nitazoxanide accelerates recovery for children with Giardia, amoebiasis, Cryptosporidium, Rotavirus and Norovirus gastroenteritis, as well as in cases where no enteropathogens are found. Methods and analysis This double blind, 1:1 randomised, placebo controlled trial is investigating the impact of oral nitazoxanide on acute gastroenteritis in hospitalised Australian Aboriginal children aged 3 months to <5 years. Dosing is based on age-based dosing. The primary endpoint is the time to resolution of€significant illness' defined as the time from randomisation to the time of clinical assessment as medically ready for discharge, or to the time of actual discharge from hospital, whichever occurs first. Secondary endpoints include duration of hospitalisation, symptom severity during the period of significant illness and following treatment, duration of rehydration and drug safety. Patients will be followed for medically significant events for 60 days. Analysis is based on Bayesian inference. Subgroup analysis will occur by pathogen type (bacteria, virus or parasite), rotavirus vaccination status, age and illness severity. Ethics and dissemination Ethics approval has been granted by the Central Australian Human Research Ethics Committee (HREC-14-221) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC2014-2172). Study investigators will ensure that the trial is conducted in accordance with the principles of the Declaration of Helsinki. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication.

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