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

NCT ID: NCT01553734

Last Updated: 2016-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-05-31

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

Conditions

Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee H Goldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Haemek Medical Center, Afula, Israel

Locations

HaEmek Medical Center

Afula, , Israel

Countries

Israel

Other Identifiers

EMC-130-11

Identifier Type: -

Identifier Source: org_study_id