Investigators from Hamad Medical Corporation, Doha, Qatar, and Providence Health Systems, Renton, WA, conducted a randomized controlled trial to assess the efficacy of palivizumab, a monoclonal antibody to respiratory syncytial virus (RSV), in treating RSV bronchiolitis in hospitalized young infants. Study participants were previously healthy children ≤3 months old with RSV bronchiolitis who presented to the Hamad Pediatric Emergency Center, Doha, Qatar, during 3 bronchiolitis seasons between May 2015 and January 2018 who required inpatient admission. The diagnosis of RSV bronchiolitis was based on a characteristic clinical presentation and a positive rapid RSV antigen test result; need for inpatient admission was based on clinical assessment. Demographic and clinical data were collected, and participants were followed up for 3 weeks after hospital discharge.
Study patients were randomized to receive a single IV dose of palivizumab (15 mg/kg) or saline placebo. Readiness for hospital discharge in study patients was based on specific criteria. The primary study outcome was inpatient readmission within 3 weeks of initial discharge. Secondary outcomes included time until readiness for discharge, need for transfer to ICU during the initial admission, and outpatient encounters for the same illness within 3 weeks of initial discharge. Outcomes were compared in study children randomized to the intervention or placebo by using chi-square tests; Kaplan-Meier survival analysis was used to compare time until readiness for discharge among infants in the 2 treatment groups.
A total of 420 children were enrolled in the study, and data were analyzed in 413: 208 in the intervention group and 205 in the placebo group. The median age was 49 days. Baseline characteristics were similar among those in the 2 groups; 10 children in the intervention group and 13 in the placebo group were initially admitted to the ICU. Among those receiving palivizumab, 11.1% required readmission within 3 weeks compared to 9.3% of those randomized to placebo (P=.51). Mean time until readiness for discharge was 29.5 hours for infants in the intervention group versus 30.2 hours for those in the placebo group (P=.83). Similarly, there were no significant differences between groups in outpatient visits within 3 weeks after discharge (19.7% and 22.0%, respectively, of infants randomized to palivizumab or placebo had an outpatient visit) or need for transfer to ICU during the initial admission (4.8% vs 6.3%, respectively, for participants randomized to the intervention or placebo group).
The authors conclude that there was no evidence that palivizumab was effective in treating healthy infants ≤3 months old with RSV bronchiolitis.
Dr Dubik has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
The most commonly identified viral pathogen for bronchiolitis is the RNA virus, RSV.1,2 RSV mortality during the first year...