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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01553734
First received: March 11, 2012
Last updated: June 14, 2015
Last verified: June 2015
  Purpose
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

Condition
Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Enrollment: 148
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized with severe community aquired pneumonia treated with azithromycin
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01553734

Locations
Israel
HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Lee H Goldstein, MD Haemek Medical Center, Afula, Israel
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01553734     History of Changes
Other Study ID Numbers: EMC-130-11 
Study First Received: March 11, 2012
Last Updated: June 14, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
QT prolongation
Azithromycin
macrolide
pneumonia
ECG changes

Additional relevant MeSH terms:
Pneumonia
Long QT Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2016