Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?

Completed

• Conditions: Pneumonia

• Registration Number: NCT01553734
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

The macrolide group of antibiotics can cause QT prolongation, and endanger the patient with life threatening arrythmias. QT prolongation caused by Azythromycin, a relatively new macrolide, is extremely rare, and was not reported in clinical trials. Our hypothesis is that patients hospitalized with severe community acquired pneumonia, usually with multiple comorbid conditions will have a higher rate of QT prolongation, compared to the clinical trials published

Detailed Description

Patients hospitalized with community aquired pneumonia will have their corrected QT measured daily during antibiotic therapy. Concomittant medications and electrolyte abnormalities that cause prolonged QT will be recorded

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-11
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Severe community acquired pneumonia
• treated with azithromycin
• age over 18 years

Exclusion Criteria

• Azithromycin initiated before hospitalization
• technically undecipherable ECG
• Permanent pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Corrected QT segment of ECG	Daily, at estimated peak antibiotic level, during index hospitalization

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel