Study design (if review, criteria of inclusion for studies)
Secondary analysis of a placebo-controlled, clinical trial
Children with CF. 221 study participants with a median of 18 months follow-up
Chronic Azithromycin (AZM) taken thrice-weekly for a planned 18 months.
Safety assessments using electrocardiogram (ECG) occurred at study enrollment, and then after 3 weeks and 18 months of participation.
Increased corrected QT interval (QTc) of â¥30Â msec was rare, at 3.4 occurrences per 100 person-years; and incidence of QTc prolongation was no higher in the AZM arm than the placebo arm (1.8 versus 5.4 per 100 person-years). No persons experienced QTc intervals above 500Â msec. Long-term chronic AZM use was not associated with increased QT prolongation.
Long-term azithromycin use is not associated with QT prolongation in children with cystic fibrosis.