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

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ClinicalTrials.gov Identifier: NCT01553734
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : August 31, 2016
Information provided by (Responsible Party):
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

Condition or disease

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 Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Azithromycin Cause QT Prolongation in Hospitalized Patients With Severe Community Acquired Pneumonia?
Study Start Date : March 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Primary Outcome Measures :
  1. Corrected QT segment of ECG [ Time Frame: Daily, at estimated peak antibiotic level, during index hospitalization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized with severe community aquired pneumonia treated with azithromycin

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553734

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

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01553734     History of Changes
Other Study ID Numbers: EMC-130-11
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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