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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01553734

Enrollment

148

Registered

2012-03-14

Start date

2012-03-31

Completion date

2013-05-31

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

QT prolongation, Azithromycin, macrolide, pneumonia, ECG changes

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Corrected QT segment of ECG	Daily, at estimated peak antibiotic level, during index hospitalization

Countries

Israel

Outcome results