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Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified May 2016 by Telethon Kids Institute
Sponsor:
Information provided by (Responsible Party):
Telethon Kids Institute
ClinicalTrials.gov Identifier:
NCT02452905
First received: May 12, 2015
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Bronchiolitis Drug: Nitazoxanide Drug: Placebo (for Nitazoxanide) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Telethon Kids Institute:

Primary Outcome Measures:
  • Severity of respiratory distress [ Time Frame: Up to day 4 ]
    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) [ Time Frame: Up to 72 hours ]
    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 [ Time Frame: Up to day 7 ]
    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 [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 to 3 days. ]
    The period of time for which hospitalisation is required for any medical reason

  • Need for interventional supportive medical care [ Time Frame: Up to day 7 ]
    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 [ Time Frame: Up to day 7 ]
    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 [ Time Frame: Up to day 7 ]
    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


Other Outcome Measures:
  • 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 ]
    The occurrence of adverse events attributed to the study treatment

  • Recurrent bronchiolitis requiring health care assessment and /or intervention [ Time Frame: Within 6 months of enrolment ]
    Recurrent bronchiolitis requiring health care assessment and/or intervention

  • Prolongation of bronchiolitis [ Time Frame: Up to 180 days post completion ]
    Prolongation of bronchiolitis beyond day 7 after enrolment


Estimated Enrollment: 124
Study Start Date: December 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nitazoxanide
Nitazoxanide 7.5mg/kg oral/nasogastric/nasoenteric tube three times per day for five days.
Drug: Nitazoxanide
Other Name: Alinia
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.
Drug: Placebo (for Nitazoxanide)

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.

  Eligibility

Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02452905

Locations
Australia, Western Australia
Telethon Kids Institute Not yet recruiting
Perth, Western Australia, Australia, 6008
Contact: Claire WADDINGTON, BMBS, MSc, MRCP (UK), DPhil    +61 481 545 093    claire.waddington@telethonkids.org.au   
Contact: Carly Foulis, BNutDiet    +61 8 9489 7654    carly.foulis@telethonkids.org.au   
Sponsors and Collaborators
Telethon Kids Institute
Investigators
Principal Investigator: Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil Telethon Kids Institute
  More Information

Responsible Party: Telethon Kids Institute
ClinicalTrials.gov Identifier: NCT02452905     History of Changes
Other Study ID Numbers: CVID/2014-02
Study First Received: May 12, 2015
Last Updated: May 3, 2016

Additional relevant MeSH terms:
Emergencies
Bronchiolitis
Disease Attributes
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 23, 2017