Study design (if review, criteria of inclusion for studies)
Randomised controlled trial.
Participants
Children under 2 years. 209 enrolled, 90 withdrew and 119 completed the study (68 prophylaxis, 51 'as required'). Mean age at enrolment (prophylaxis = 14.1 months, 'as required' = 12.7 months). Followed up for between 5 and 7 years. Data collected at yearly intervals from year 1.
Interventions
Continuous cephalexin versus placebo.
Outcome measures
Primary outcome: Lung function. Secondary outcomes: 1. Growth 2. Inpatient days 3. Courses of 'as required' oral antibiotics 4. Participants with isolates of common pathogens 5. P. aeruginosa
Main results
Of 209 children enrolled, 119 completed a 5- to 7-year course of therapy. Mean age at enrollment was 15.6 and 14.1 months in the cephalexin and placebo groups, respectively. Respiratory cultures from children treated with cephalexin were significantly less likely to be positive for S aureus (6.0% vs 30.4%; P <.001). They were, however, much more likely to be positive for Pseudomonas aeruginosa (25.6% vs 13.5%; P <.009). These differences became apparent in the first year after enrollment and persisted over the duration of the study. In contrast to these microbiologic differences, there were no differences in clinical outcome measures, including radiographic (Brasfield score, 23.4 vs 23.2) or anthropometric scores or pulmonary function.
Authors' conclusions
Although long-term prophylaxis with cephalexin successfully delayed the acquisition of S aureus, it enhanced colonization with P aeruginosa and did not lead to clinically significant improvement in major health outcomes. These data do not support routine antistaphylococcal prophylaxisin otherwise healthy infants and young children with CF.