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NCT01553734 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01553734
Other study ID # EMC-130-11
Secondary ID
Status Completed
Phase N/A
First received March 11, 2012
Last updated August 30, 2016
Start date March 2012
Est. completion date May 2013

Study information
Verified date August 2016
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 148
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel HaEmek Medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corrected QT segment of ECG Daily, at estimated peak antibiotic level, during index hospitalization Yes
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