MedTrace Logo

Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children

NCT02165813 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-02-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nitazoxanide

Nitazoxanide is a synthetic drug of the nitrothiazolide class. The main metabolite of NTZ is tizoxanide. The active ingredient is Nitazoxanide (2-acetyloxy-N(5-nitro-2-thiazolyl)benzamide), a synthetic agent for oral administration, at a concentration of 100 mg/5 ml.

DRUG

placebo

An oral suspension is supplied as a pink coloured powder formulation (sugar) that is reconstituted with 48 mL water prior to use to a final volume of 60 mls.

Sponsors & Collaborators

  • The University of Western Australia

    collaborator OTHER

  • Menzies School of Health Research

    collaborator OTHER

  • Telethon Kids Institute

    lead OTHER

Principal Investigators

  • Tom Snelling · Sydney University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2021-04-21
Completion
2021-06-06

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02165813 on ClinicalTrials.gov