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primary studies published RCT

Long-term azithromycin use is not associated with QT prolongation in children with cystic fibrosis.

  • Year: 2020
  • Date: 2020
  • Author: Magaret AS
Source

J Cyst Fibros. 2020 Nov 24:S1569-1993(20)30908-5. doi: 10.1016/j.jcf.2020.11.005.

Study design (if review, criteria of inclusion for studies)

Secondary analysis of a placebo-controlled, clinical trial

Participants

Children with CF. 221 study participants with a median of 18 months follow-up

Interventions

Chronic Azithromycin (AZM) taken thrice-weekly for a planned 18 months.

Outcome measures

Safety assessments using electrocardiogram (ECG) occurred at study enrollment, and then after 3 weeks and 18 months of participation.

Main results

Increased corrected QT interval (QTc) of ≥30 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 500 msec. Long-term chronic AZM use was not associated with increased QT prolongation.

Authors' conclusions

Long-term azithromycin use is not associated with QT prolongation in children with cystic fibrosis.

Keywords: Adolescent; Adult; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Infection; pharmacological_intervention; Pneumonia; Respiratory Tract Diseases; Respiratory Tract Infections; Macrolides; Anti-Inflammatory Agents; Anti-Inflammatory Agents - excl Steroids;