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

This study is currently recruiting participants.
Verified March 2012 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01553734
First received: March 11, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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

Estimated Enrollment: 400
Study Start Date: March 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553734

Contacts
Contact: Lee H Goldstein, MD 972506787786 goldstein_le@clalit.org.il

Locations
Israel
HaEmek Medical Center Recruiting
Afula, Israel, 18101
Contact: Lee H Goldstein, MD     972506787786     goldstein_le@clalit.org.il    
Principal Investigator: Lee H Goldstein, MD            
Sub-Investigator: Abdallah Fuaz, MD            
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Lee H Goldstein, MD Haemek Medical Center, Afula, Israel
  More Information

No publications provided

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: March 13, 2012
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
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013