Trial from ClinicalTrials.gov

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Trial ID
NCT02452905
Ethics application status
Date submitted
12/05/2015
Date registered
12/05/2015
Date last updated
10/10/2017

Titles & IDs
Public title
Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
Scientific title
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
Secondary ID [1] 0 0
CVID/2014-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: drugs - Nitazoxanide
Treatment: drugs - Placebo (for Nitazoxanide)

Active Comparator: Nitazoxanide - Nitazoxanide 7.5mg/kg oral/nasogastric/nasoenteric tube three times per day for five days.

Placebo Comparator: 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.


Treatment: drugs: Nitazoxanide


Treatment: drugs: Placebo (for Nitazoxanide)


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

Outcomes
Primary outcome [1] 0 0
Severity of respiratory distress - The calculation of a Respiratory Assessment Change Score (RACS) by the use of the Respiratory Distress Assessment Instrument (RDAI) from baseline (day 1) to study day 4 adjusted for the standardised change in respiratory rate with points being assigned by change increments of 10% Internal reliability and responsiveness of the RACS as a measure of respiratory distress in infants has been previously demonstrated and it correlates well with other measures of respiratory distress
Timepoint [1] 0 0
Up to day 4
Secondary outcome [1] 0 0
Nasopharyngeal excretion of Respiratory Syncytial Virus (RSV) - The change in nasopharyngeal viral excretion as measured by Polymerase Chain Reaction (PCR)
Timepoint [1] 0 0
Up to 72 hours
Secondary outcome [2] 0 0
Duration of parent reported solicited symptoms associated with bronchiolitis during and after treatment - The time until the severity of ALL solicited symptoms associated with bronchiolitis (loss of appetite, activity level, respiratory effort and irritability) have first been assessed as mild or normal from the day of randomisation to the end of study day 7
Timepoint [2] 0 0
Up to day 7
Secondary outcome [3] 0 0
Actual duration of hospital admission for any reason - The period of time for which hospitalisation is required for any medical reason
Timepoint [3] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 to 3 days.
Secondary outcome [4] 0 0
Need for interventional supportive medical care - The use of oxygen therapy, supportive ventilation, admission to the Intensive Care Unit (ICU) and supportive hydration therapy (NG or IV). Duration of use is calculated from the calendar day of randomisation to the date of cessation
Timepoint [4] 0 0
Up to day 7
Secondary outcome [5] 0 0
Severity of parent reported solicited symptoms associated with bronchiolitis during and after treatment - The time until the severity of ALL solicited symptoms associated with bronchiolitis (loss of appetite, activity level, respiratory effort and irritability) have first been assessed as mild or normal from the day of randomisation to the end of study day 7
Timepoint [5] 0 0
Up to day 7
Secondary outcome [6] 0 0
Duration of interventional supportive medical care - The use of oxygen therapy, supportive ventilation, admission to the Intensive Care Unit (ICU) and supportive hydration therapy (NG or IV). Duration of use is calculated from the calendar day of randomisation to the date of cessation
Timepoint [6] 0 0
Up to day 7

Eligibility
Key inclusion criteria
- Aged greater than or equal to 1 month to less than or equal to 12 months

- 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
Minimum age
1 Month
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of symptoms of bronchiolitis (breathing difficulty, difficulty feeding,
cough, poor feeding) for greater than or equal to 48 hours at the time of enrolment

- 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

TEMPORARY EXCLUSION CRITERIA

- 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

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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Telethon Kids Institute - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral
infection.This study evaluates whether treatment with nitazoxanide (NTZ) reduces the duration
and severity of respiratory symptoms caused by bronchiolitis. Half of the participants will
receive NTZ while the other half will receive a placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil
Address 0 0
Telethon Kids Institute
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
Contact person responsible for updating information