Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
NCT ID: NCT02452905
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-12-31
2018-07-31
Brief Summary
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Detailed Description
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This study will determine whether NTZ is an effective empirical treatment for bronchiolitis. It will also help us to understand what effect NTZ has on the amount of virus present and how viral load changes over the course of the disease. If this study shows that NTZ is a useful treatment, then a larger study will be conducted enrolling infants that present to primary care facilities.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nitazoxanide
Nitazoxanide 7.5mg/kg oral/nasogastric/nasoenteric tube three times per day for five days.
Nitazoxanide
Placebo
The placebo is identical to the active drug described above except that it does not contain the active compound nitazoxanide. It is reconstitutes, administered and dosed as per the active study drug.
Placebo (for Nitazoxanide)
Interventions
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Nitazoxanide
Placebo (for Nitazoxanide)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with bronchiolitis by the assessing doctor
* Parent/legally responsible carer has provided informed consent for their infant/child to participate in the study
* Parent/legally responsible carer able and willing to comply with the requirements of the protocol
* Parent/legally responsible carer willing to attend a study follow up visit on study day 3 if their infant/child has previously been discharged from hospital
* 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
* Infants and children whose parent is willing to allow the study team to obtain an interim medical history from the participants electronic medical records (including immunisation records) and/or from the participants general practitioner or other medical professional for the period from enrolment to study day 180
Exclusion Criteria
* Born at gestational age of less than 32 weeks
* 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, significant neurological disease including history of seizure disorder, significant impairment/alteration of the immune system including congenital immunodeficiency or any other disorder considered relevant by a medically qualified investigator
* Requiring admission to intensive care unit at enrolment
* Clinical suspicion of illness other than bronchiolitis
* Contraindication to the study drug or placebo (hypersensitivity), medical treatment with medication which in the opinion of the admitting team would make the child unsuitable for the study
* 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
* Previously enrolled in the study
* Parent less than 18 years of age
* Receipt of an anti-viral medication within the previous 7 days
* Inability to tolerate either the oral or nasogastric route (e.g. ileus)
* Any systemic corticosteroid (or equivalent) treatment in 14 days prior to enrolment
1 Month
12 Months
ALL
No
Sponsors
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Telethon Kids Institute
OTHER
Responsible Party
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Principal Investigators
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Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil
Role: PRINCIPAL_INVESTIGATOR
Telethon Kids Institute
Locations
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Telethon Kids Institute
Perth, Western Australia, Australia
Countries
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Other Identifiers
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CVID/2014-02
Identifier Type: -
Identifier Source: org_study_id