Back to resultsFinding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
Primary Purpose
Bronchiolitis
Status
Withdrawn
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Nitazoxanide
Placebo (for Nitazoxanide)
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis
Eligibility Criteria
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
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
Sites / Locations
- Telethon Kids Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitazoxanide
Placebo
Arm Description
Nitazoxanide 7.5mg/kg oral/nasogastric/nasoenteric tube three times per day for five days.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Nasopharyngeal excretion of Respiratory Syncytial Virus (RSV)
The change in nasopharyngeal viral excretion as measured by Polymerase Chain Reaction (PCR)
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
Actual duration of hospital admission for any reason
The period of time for which hospitalisation is required for any medical reason
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02452905
Brief Title
Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The drug manufacture were unable to produce liquid formulation of the IMP within a reasonable time frame so the funding was relinquished.
Study Start Date
December 2016 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telethon Kids Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Nitazoxanide (NTZ) is a novel anti-infective medication that is licenced for use in the United States (US), including in children and infants for treating some infections. It is in the thiazolide class of antimicrobials and has been shown to have in vitro and/or clinical activity against a broad spectrum of pathogens, including a range of viruses, parasites and bacteria.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nitazoxanide
Arm Type
Active Comparator
Arm Description
Nitazoxanide 7.5mg/kg oral/nasogastric/nasoenteric tube three times per day for five days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alinia
Intervention Type
Drug
Intervention Name(s)
Placebo (for Nitazoxanide)
Primary Outcome Measure Information:
Title
Severity of respiratory distress
Description
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
Time Frame
Up to day 4
Secondary Outcome Measure Information:
Title
Nasopharyngeal excretion of Respiratory Syncytial Virus (RSV)
Description
The change in nasopharyngeal viral excretion as measured by Polymerase Chain Reaction (PCR)
Time Frame
Up to 72 hours
Title
Duration of parent reported solicited symptoms associated with bronchiolitis during and after treatment
Description
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
Time Frame
Up to day 7
Title
Actual duration of hospital admission for any reason
Description
The period of time for which hospitalisation is required for any medical reason
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 to 3 days.
Title
Need for interventional supportive medical care
Description
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
Time Frame
Up to day 7
Title
Severity of parent reported solicited symptoms associated with bronchiolitis during and after treatment
Description
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
Time Frame
Up to day 7
Title
Duration of interventional supportive medical care
Description
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
Time Frame
Up to day 7
Other Pre-specified Outcome Measures:
Title
Occurrence of adverse events attributed to the study treatment
Description
The occurrence of adverse events attributed to the study treatment
Time Frame
Participants will be followed for the duration of enrolment and up to 180 days post completion
Title
Recurrent bronchiolitis requiring health care assessment and /or intervention
Description
Recurrent bronchiolitis requiring health care assessment and/or intervention
Time Frame
Within 6 months of enrolment
Title
Prolongation of bronchiolitis
Description
Prolongation of bronchiolitis beyond day 7 after enrolment
Time Frame
Up to 180 days post completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil
Organizational Affiliation
Telethon Kids Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Telethon Kids Institute
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments
We'll reach out to this number within 24 hrs