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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02165813




Registration number
NCT02165813
Ethics application status
Date submitted
9/06/2014
Date registered
18/06/2014
Date last updated
8/02/2024

Titles & IDs
Public title
Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children
Scientific title
A Randomised, Placebo-controlled Trial of Oral Nitazoxanide for the Empiric Treatment of Acute Gastroenteritis Among Australian Indigenous Children
Secondary ID [1] 0 0
NICEGUT
Universal Trial Number (UTN)
Trial acronym
NICEGUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroenteritis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nitazoxanide
Treatment: Drugs - placebo

Active comparator: Nitazoxanide - oral nitazoxanide suspension twice daily for 3 days

Placebo comparator: Placebo - oral placebo suspension twice daily for 3 days


Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time of significant illness
Timepoint [1] 0 0
Between randomisation and hospital discharge (expected to be within 7 days)
Secondary outcome [1] 0 0
Time to hospital discharge
Timepoint [1] 0 0
Between randomisation and hospital discharge (expected to be within 7 days)

Eligibility
Key inclusion criteria
1. Infant /child between =>3 months and <5 years of age
2. Infant/ child identified as Indigenous by the legally responsible care-giver
3. Infant /child has been/will be admitted to hospital for acute infectious gastroenteritis (in the opinion of the admitted doctor and/or study doctor/nurse )
4. The legally responsible care-giver is willing for their infant/ child to participate in the study and who would be expected to comply with the requirements of the protocol, including being able and willing to be contacted by telephone after discharge where necessary
5. The legally responsible care-giver is willing to allow other parties involved in the treatment of his or her child (including the general practitioner, paediatrician, hospital medical and nursing staff, community clinic staff) to be notified of participation in the trial
6. The legally responsible care-giver is willing to allow to allow the study team to obtain a vaccination history from Australian Childhood Immunisation Register (ACIR) and/or local provider
7. The legally responsible care-giver is willing to allow the study team to obtain an interim medical history from the participant's electronic medical records and/or from the participant's general practitioner for the period from enrolment to study day 60
8. Informed consent for the infant's/child's participation in the study has been given by the legally responsible care-giver
Minimum age
3 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Admitted for =>48 hours at the point of enrolment
2. Duration of symptoms of greater than 14 days without apparent worsening of symptoms consistent with an acute pathology
3. Presence of grossly bloody diarrhoea
4. Clinical suspicion of non-infectious cause (e.g. diagnosed with a pre-existing medical condition predisposing to non-infectious diarrhoea, for example inflammatory bowel disease) except for environmental enteropathy)
5. Contraindication to the study drug or placebo (e.g. allergy)
6. Diagnosis of infection with an enteric pathogen where anti-microbial treatment with an alternative antimicrobial is the standard of care (e.g. Shigella sp.)
7. Inability to tolerate either the oral or nasogastric route (e.g. ileus)
8. Clinical suspicion of intestinal obstruction including bilious vomiting
9. Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
10. Receipt of more than 2 weeks of immuno-suppressants or immune modifying drugs, (e.g. prednisolone >0.5 mg/kg/day)
11. Receipt of investigational drug/vaccine, other than the drugs used in the study, within 30 days prior to receiving the first dose of NTZ or their planned use during the study period, until 1 month after the administration of the final dose of NTZ
12. Previously enrolled in the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/06/2021
Sample size
Target
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Alice Springs Hospital - Alice Springs
Recruitment hospital [2] 0 0
Royal Darwin Hospital - Darwin
Recruitment postcode(s) [1] 0 0
0872 - Alice Springs
Recruitment postcode(s) [2] 0 0
0800 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Menzies School of Health Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02165813
Trial related presentations / publications
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. 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. 2018 Feb 1;8(2):e019632. doi: 10.1136/bmjopen-2017-019632.
Public notes

Contacts
Principal investigator
Name 0 0
Tom Snelling
Address 0 0
Sydney University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02165813