Study design (if review, criteria of inclusion for studies)
Audit study
Participants
Children with CF, <24 months old. Tertiary hospital in Ireland's mid-West
Interventions
Comparison between children with CF, <24 months old, who received palivizumab over a five year period and all eligible children for the prior five year period who had not received the product (also CF patients). Palivizumab was administered to both cohorts in their first year of life.
Outcome measures
Hospitalisation rates. Incidence of RSV and Pseudomonas aeruginosa infection.
Main results
A total of 19 patients who received palivizumab were included in the study; comparision was made with a retrospective control group of 30 patients. Prophylactic palivizumab did not prevent hospitalisation for 10/19 patients, 3 of whom were affected by RSV. This was significantly greater than in the control group, where no hospitalisations were recorded (p < 0.0001). P. aeruginosa was isolated in one case from the study cohort, while no P. aeruginosa was detected in the control group.
Authors' conclusions
This study, the first of its kind from Ireland where CF prevalence is highest, does not provide unequivocal support for prophylactic use of palivizumab in CF patients under 2 years. Despite being derived from a small sample size, based on these data and complementary clinical observation, we have discontinued such prophylaxis. However, should reported incidence of RSV-related hospitalisation increase, there is scientific plausibility for appropriately powered, randomised, controlled trials of palivizumab.