NCT01553734

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

March 11, 2012

Last Update Submit

August 30, 2016

Conditions

Pneumonia

Keywords

QT prolongationAzithromycinmacrolidepneumoniaECG changes

Outcome Measures

Primary Outcomes (1)

  • Corrected QT segment of ECG

    Daily, at estimated peak antibiotic level, during index hospitalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized with severe community aquired pneumonia treated with azithromycin

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

PneumoniaLong QT Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lee H Goldstein, MD

    Haemek Medical Center, Afula, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)