McCallum 2013.
| Methods | Randomised controlled trial | |
| Participants | Children aged ≤ 18 months, admitted with a clinical diagnosis of bronchiolitis (according to standardised hospital protocols; ≤ 18 months, with cough and coryza, wheezing +/‐ crackles, respiratory distress with both tachypnoea (respiratory rate > 50 breaths/minute) and retractions). The major reason why 450 children did not meet the inclusion criteria was because they did not require supplemental oxygen or were admitted over the weekend. During recruitment, 21 children admitted into intensive care were excluded | |
| Interventions | A single large dose (30 mg/kg) of azithromycin within 24 hours of hospitalisation | |
| Outcomes | Primary outcomes: length of stay for respiratory illness ‐ time from admission to time for 'ready for discharge' (SpO2 consistently > 94% in air for > 16 hours and feeding adequately), duration of O2 requirement Other outcomes: any respiratory‐related readmissions within 6 months of discharge and identification of respiratory viruses and bacterial pathogens |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was stratified by age (≤ 6 or > 6 months), ethnicity (Indigenous or non‐Indigenous) and site (Darwin or Townsville). Randomisation was by computer‐generated permuted blocks |
| Allocation concealment (selection bias) | Low risk | Treatment allocation was concealed by opaque stickers. Upon enrolment, children were assigned the next treatment on the appropriate stratified list |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Neither the study team (researchers, hospital staff) nor parents were aware of the assigned treatment group until the end of the trial. The placebo medication was manufactured by the Institute of Drug Technology Australia Limited (Melbourne, Victoria). It had a similar smell and taste to active azithromycin. Azithromycin (Pfizer, Australia) was repackaged by IDT. Both medications were prepared as powder in identical opaque bottled and sealed with an aluminium foil |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 97 children were recruited and data from 96 children were analysed. One participant was excluded from the analysis of primary outcomes; they had received a macrolide in the previous 7 days (this child was randomised to placebo). This child was included in the analysis of secondary outcomes |
| Selective reporting (reporting bias) | Low risk | |
| Other bias | Low risk | Study was funded by grants from the Channel 7 Foundation (seed funding 2007), the Financial Markets Foundation for Children (for 2 years), and supported by a National Health and Medical Research Council (NHMRC) Centre for Research Excellence in Lung Health of Aboriginal and Torres Strait Islander Children (grant number 1040830). GBM is supported by a NHMRC scholarship (grant 1055262), AC is funded by a NHMRC practitioner fellowship (grant 545216). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript |