Investigators: Julie Marsh, Nelly Newall, Tom Snelling
External collaborators: Ross Andrews (Menzies School of Health Research), Carl Kirwood (Bill and Melinda Gates Foundation), Peter Morris (Menzies School of Health Research), Josh Francis (Menzies School of Health Research), Mark Naunton (University of Canberra), Keith Grimwood (Griffith University), Roy Robins-Browne (University of Melbourne), Robert Baird (Royal Darwin Hospital), Deborah Fearon (Alice Springs Hospital)
The study aims to assess the impact of oral nitazoxanide (antimicrobial) on the length of symptoms among Aboriginal children admitted to hospital with gastroenteritis aged between three months and five years old. Up to 300 children will be enrolled from the Royal Darwin Hospital and Alice Springs Hospital. The children receive the nitazoxanide treatment or a placebo for three days. We follow up the children for 60 days and at completion we will assess any differences between the two groups.There are currently 190 children enrolled in this study.
Aboriginal children experience a large burden of disease from gastroenteritis. Those living remotely have a particularly high burden of disease, and frequently require aero-medical retrieval to hospital for management of gastroenteritis. There are few effective treatment options for acute diarrhoeal illness in children. Management is limited to supportive care with fluid and electrolyte replacement to prevent life-threatening dehydration, correct electrolyte imbalances and improve nutritional status.
Nitazoxanide (NTZ) is an antimicrobial with broad-spectrum activity against many of the pathogens implicated in acute gastroenteritis in high-burden settings, including in remote Aboriginal children. In other settings, NTZ treatment has been successfully used to treat gastroenteritis caused by a wide range of pathogens.
Our team successfully obtained an NHMRC project grant to conduct a pragmatic, placebo controlled, randomised clinical trial to investigate the potential benefit of using NTZ as an empiric treatment strategy in Aboriginal children hospitalised with acute gastroenteritis. This study is currently recruiting participants and is planned to finish in the next two years.