A phase II double-blind randomised, placebo-controlled clinical trial of oral nitazoxanide for the treatment of bronchiolitis in infants presenting to hospital emergency departments.

Phase 2

Withdrawn

• Conditions: Bronchiolitis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12615000590561
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Aged greater than or equal to 1 month to less than or equal to 12 months
2. Diagnosed with bronchiolitis by the assessing doctor
3. Parent/ legally responsible carer has provided informed consent for their infant/ child to participate in the study
4. Parent/ legally responsible carer able and willing to comply with the requirements of the protocol
5. Parent/ legally responsible carer able and willing to attend a study follow up visit on study day 3 if their infant/child has previously been discharged from hospital
6. Parent/ legally responsible carer 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
7. Infants and children whose parent is willing to allow the study team to obtain an interim medical history from the participant’s electronic medical records (including immunisation records)and/or from the participant’s general practitioner or other medical professional for the period
from enrolment to study day 180

Exclusion Criteria

1. Presence of symptoms of bronchiolitis (breathing difficulty, difficulty feeding, cough, poor
feeding) for greater than or equal to 48 hours at the point of enrollment
2. Born at a gestational age of less than 32 weeks
3. Has a history of any condition associated with risk of severe bronchiolitis including:
*Significant cardiovascular disease, including congenital heart disease
*Significant respiratory disease, including chronic lung disease
*Trisomy 21 (Down’s syndrome)
*Significant neurological disease (including history of seizure disorder)
*Significant impairment/ alteration of the immune system (including congenital
immunodeficiency)
*Any other disorder considered relevant by a medically qualified investigator
4. Requiring admission to intensive care unit at enrollment
5. Clinical suspicion of illness other than bronchiolitis
6. Contraindication to the study drug or placebo (e.g. allergy)Medical condition or treatment with
medication which in the opinion of the admitting team would make the child unsuitable for the
trial
7. 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
8. Previously enrolled in the trial
9. Parent less than 18 years of age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of treatment with nitazoxanide compared to placebo on the severity of respiratory distress. [The Respiratory Assessment Change Scores (RACS) as measured by the change in Respiratory Distress Assessment Instrument (RDAI) at day 1 and study day 4 (two time points) adjusted for the change in respiratory rate]