Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a multi-centre (RDH and ASH), phase IV, double-blind, randomised, placebo-controlled
Bayesian adaptive trial of oral NTZ for the treatment of acute gastroenteritis requiring
admission to hospital. A maximum of 300 children aged between three months and less than five
years of age will be enrolled. Study participation is from the point of enrolment until 60
days after enrolment. Enrolment will occur within 48 hours of admission to hospital. Enrolled
participants will be randomised 1:1 to Nitazoxanide (NTZ) or placebo. Other treatment and
management will be as per the standard of care described in the admitting hospital's
guidelines and will be ultimately the decision and responsibility of the named medical
consultant. Stool samples will be collected at the point of admission. Solicitation of
symptoms will be by review of routinely collected medical data recorded in the participant's
medical record, and will be supplemented by completion of study specific diary cards after
discharge (for the first 210 enrolments). Attempts will be made to contact participants at
day 7 after enrolment (by telephone if already discharged) to ascertain symptoms occurring in
the intervening period. At days 30 and 60 (for first 210 enrolments ) and Day 60 (for
enrolment #211 onwards) after enrolment a clinical record review will be conducted for all
participants to ascertain health care attendances following discharge.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Telethon Kids Institute
Collaborators:
Menzies School of Health Research The University of Western Australia