Voriconazole-Induced QT Interval Prolongation: A Prospective Study

August 4, 2020 updated by: Rabin Medical Center
The antifungal voriconazole is effective for the treatment of invasive fungal infections in immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the incidence and clear recommendations for QT follow-up have not been published. This prospective observational study aimed at describing the incidence of voriconazole induced- QT interval prolongation in the pediatric population and determine the risk factors for this phenomenon.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Recruiting
        • Schneider childrens medical center of Isreal
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liat Ashkenazy-Hoffnung, MD
        • Sub-Investigator:
          • Itzhak Levy, MD, MPH
        • Sub-Investigator:
          • Havatzelet Yarden-Bilavsky, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged 0-20 years treated with oral or IV voriconazole at the Schneider Children's Medical Center from Oct 31st 2016.

Description

Inclusion Criteria:

  • oral or IV treatment with voriconazole

Exclusion Criteria:

  • No data prior to initiation of voriconazole treatment on QT interval (baseline ECG)
  • Renal insufficiency or dialysis treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QT interval prolongation
Time Frame: up to three months of treatment
up to three months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2016

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0483-16-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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