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

NCT02452905 | Withdrawn Phase 2 DMC

• 1 other identifier: CVID/2014-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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

  Up to day 4

Secondary Outcomes (6)

• Nasopharyngeal excretion of Respiratory Syncytial Virus (RSV)

  Up to 72 hours

• Duration of parent reported solicited symptoms associated with bronchiolitis during and after treatment

  Up to day 7

• Actual duration of hospital admission for any reason

  Participants will be followed for the duration of hospital stay, an expected average of 1 to 3 days.

• Need for interventional supportive medical care

  Up to day 7

• Severity of parent reported solicited symptoms associated with bronchiolitis during and after treatment

  Up to day 7

Other Outcomes (3)

• Occurrence of adverse events attributed to the study treatment

  Participants will be followed for the duration of enrolment and up to 180 days post completion

• Recurrent bronchiolitis requiring health care assessment and /or intervention

  Within 6 months of enrolment

• Prolongation of bronchiolitis

  Up to 180 days post completion

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR

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

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

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)

Interventions

Nitazoxanide DRUG

Also known as: Alinia

Nitazoxanide

Placebo (for Nitazoxanide) DRUG

Placebo

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Telethon Kids Institute: lead

Study Sites (1)

Telethon Kids Institute

Perth, Western Australia, 6008, Australia

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Claire WADDINGTON, BMBS MSc MRCP (UK) DPhil

  Telethon Kids Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 25, 2015
• Study Start: December 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: July 1, 2018
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

AU (1)