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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Telethon Kids Institute
Perth, Western Australia, Australia
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
Time frame: Up to day 4
Nasopharyngeal excretion of Respiratory Syncytial Virus (RSV)
The change in nasopharyngeal viral excretion as measured by Polymerase Chain Reaction (PCR)
Time frame: Up to 72 hours
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
Time frame: Up to day 7
Actual duration of hospital admission for any reason
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.
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
Time frame: Up to day 7
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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
Time frame: Up to 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
Time frame: Up to day 7