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OpenTrials
Completed

NCT Number: NCT01553734

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

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

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Key information

Conditions

Pneumonia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Infections Long QT Syndrome Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HaEmek Medical Center

Afula, 18101, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Corrected QT segment of ECG

    Time frame: Daily, at estimated peak antibiotic level, during index hospitalization

Interested in participating?

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Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2012
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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