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A Randomised, Placebo Controlled Trial of Oral Nitazoxanide for the Empiric Treatment of Acute Gastroenteritis Among Australian Aboriginal Children

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A Randomised, Placebo Controlled Trial of Oral Nitazoxanide for the Empiric Treatment of Acute Gastroenteritis Among Australian Aboriginal Children Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2017-019632 on 1 February 2018. Downloaded from 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,1 Charlie McLeod,2 Peter Morris,3,4 Asha Bowen,2,3 Mark Naunton,5 Jonathan Carapetis,1,2 Keith Grimwood,6 Roy Robins-Browne,7 Carl D Kirkwood,8 Robert Baird,9 David Green,10 Ross Andrews,3 Deborah Fearon,10 Joshua Francis,3,4 Julie A Marsh,1,11 Thomas Snelling1 To cite: Waddington CS, ABSTRACT Strengths and limitations of this study McLeod C, Morris P, et al. The Introduction Diarrhoeal disease is the second NICE-GUT trial protocol: a leading cause of death in children under 5 years ► NICE-GUT is the first study in Australia to evaluate randomised, placebo controlled globally, killing 525 000 annually. Australian trial of oral nitazoxanide for the impact of nitazoxanide on acute gastroenteritis Aboriginal and Torres Strait Islander (hereafter the empiric treatment of acute in Aboriginal children. Aboriginal) children suffer a high burden of disease. gastroenteritis among Australian ► This pragmatic randomised control trial is based Randomised trials in other populations suggest Aboriginal children. BMJ Open on Bayesian adaptive design, an innovative trial nitazoxanide accelerates recovery for children with 2018;8:e019632. doi:10.1136/ methodology that overcomes some of the limitations bmjopen-2017-019632 Giardia, amoebiasis, Cryptosporidium, Rotavirus and encountered in trials informed by frequentist design. Norovirus gastroenteritis, as well as in cases where ► Prepublication history and ► While Bayesian adaptive trials are becoming no enteropathogens are found. additional material for this increasingly popular, they are yet to be established Methods and analysis This double blind, 1:1 paper are available online. To and accepted as routine research practice. randomised, placebo controlled trial is investigating view these files, please visit ► The investigator group will rapidly ensure translation the impact of oral nitazoxanide on acute the journal online (http:// dx. doi. of research findings into clinical practice and health gastroenteritis in hospitalised Australian Aboriginal http://bmjopen.bmj.com/ org/ 10. 1136/ bmjopen- 2017- policy. 019632). children aged 3 months to <5 years. Dosing is based ► Loss to follow-up is likely to be encountered in this on age-based dosing. The primary endpoint is the study. Received 14 September 2017 time to resolution of ‘significant illness’ defined as Revised 27 November 2017 the time from randomisation to the time of clinical Accepted 7 December 2017 assessment as medically ready for discharge, or to the time of actual discharge from hospital, whichever INTRODUCTIon occurs first. Secondary endpoints include duration of Acute gastroenteritis is the leading cause of hospitalisation, symptom severity during the period of global childhood mortality and morbidity, on October 4, 2021 by guest. Protected copyright. significant illness and following treatment, duration and disproportionately affects those in of rehydration and drug safety. Patients will be resource-poor settings.1 The GEMS study2 followed for medically significant events for 60 days. quantified the pathogen-specific burden of Analysis is based on Bayesian inference. Subgroup enteric disease in several high burden low-in- analysis will occur by pathogen type (bacteria, virus come countries; in that study, infection with or parasite), rotavirus vaccination status, age and illness severity. enterotoxigenic and enteropathogenic Esch- Ethics and dissemination Ethics approval has been erichia coli in infants 0–11 months and Cryp- granted by the Central Australian Human Research tosporidium in toddlers 12–23 months was Ethics Committee (HREC-14–221) and the Human associated with an increased 60-day mortality. Research Ethics Committee of the Northern Territory Australian Aboriginal children also experi- Department of Health and Menzies School of Health ence a disproportionate burden of disease 3 For numbered affiliations see Research (HREC2014-2172). Study investigators will compared with non-Aboriginal children. end of article. ensure that the trial is conducted in accordance with Although the introduction of rotavirus vacci- the principles of the Declaration of Helsinki. Individual nation in 2006 has reduced disease burden, Correspondence to participant consent will be obtained. Results will be vaccine effectiveness in Aboriginal children Dr Thomas Snelling; disseminated via peer-reviewed publication. has been low compared with that observed tom. snelling@ telethonkids. Trial registration number ACTRN12614000381684. org. au in non-Aboriginal Australian children.4 Waddington CS, et al. BMJ Open 2018;8:e019632. doi:10.1136/bmjopen-2017-019632 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2017-019632 on 1 February 2018. Downloaded from Gastroenteritis outbreaks are well described among hospitals serving the Northern Territory (NT) of Australia. Aboriginal children living in remote central and northern Aboriginal people represent 30% of the population in Australia. These epidemics place enormous strain on the NT.16 Most of the NT is classified as extremely remote; remote health clinics, aeromedical retrieval services and hospitalisation frequently requires aeromedical retrieval. hospital facilities.5 6 An effective oral treatment for the Diarrhoea is the most prevalent condition at admission management of gastroenteritis would have a substantial among infants and young adults in the NT, occurring in impact in this setting in reducing disease burden and around 300 admissions per 1000 Aboriginal population.3 potentially reducing sequelae associated with prolonged Epidemics of gastroenteritis are also well described in this and recurrent intestinal infections such as malnutrition, population.5 stunting and cognitive impairment.7 8 Therefore, while disease prevention remains the long-term goal, effec- Objectives tive treatment strategies are still needed to reduce the The primary objective of the NICE-GUT trial is to deter- health, social and economic and impact of childhood mine whether empiric treatment with oral nitazoxa- gastroenteritis. nide (NTZ), compared with placebo, reduces the duration Nitazoxanide, a thiazolide antimicrobial developed of significant illness in Aboriginal children hospitalised in the 1980s, has been shown to have broad-spectrum for acute gastroenteritis. in vitro and/or clinical activity against a wide range of enteric pathogens including Giardia, Entamoeba, Bacte- Outcomes roides, Clostridium, Cryptosporidium, Rotavirus and Noro- The primary outcome is ‘the time period of significant virus.9–15 Nitazoxanide is administered orally, is heat illness’, defined as the time from randomisation until either stable, and has proven to be safe and well tolerated in (1) the time to achieve a score ≥2 on the ‘medical readi- children,9 making it suitable for use in remote and low ness for discharge’ scoring system (table 2) as assessed by resource settings. To date, clinical trials of nitazoxanide the study doctor or study nurse or (2) the time to actual have been conducted in low and middle income coun- hospital discharge, except for children who die, abscond tries, where data have emerged to support its empirical or are transferred to other health facilities, whichever is use for the treatment of acute gastroenteritis regardless sooner. Assessment of medical readiness for discharge is of aetiology.9 Results of these trials cannot be automati- based on medical factors only and specifically excludes cally extrapolated to our high-income (but high disease social issues that may influence actual discharge decisions. burden) setting. Further details are provided under study procedures. Here we describe a clinical trial protocol to investigate if Secondary outcomes include (1) duration of hospi- nitazoxanide is clinically beneficial for the empirical treat- talisation, defined as the time from randomisation until ment of acute gastroenteritis among Australian Aborig- actual discharge from hospital (including time after inal children. Clinical trials in high burden and often low being assessed as medically suitable for discharge); (2) http://bmjopen.bmj.com/ resourced settings are challenging. It is important to strike number of stools and vomiting episodes during the a balance between gathering reliable data pertaining to ‘time period of significant illness’; (3) the presence and relevant endpoints against the challenges of working with severity of symptoms from the time of randomisation to a disparate and culturally diverse population for whom day 7, based on the number of vomits/diarrhoea, overall English language literacy and understanding of research symptoms and activity level; (4) the presence and severity may be limited and in whom pragmatic public health solu- of dehydration based on WHO guidelines (online supple- tions are needed in a timely manner. By using the prin- mentary appendix 1)17; and (5) the time between starting cipals of pragmatic trial design, cross-cultural working intravenous, intraosseous or nasogastric rehydration on October 4, 2021 by guest. Protected copyright. and a Bayesian adaptive statistical approach, this trial will or randomisation (whichever occurs later) and ceasing provide timely, relevant data to inform the management rehydration. of gastroenteritis in these children.
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