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Voriconazole-Induced QT Interval Prolongation: A Prospective Study

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04502355
Collaborator
(none)
60
Enrollment
1
Location
50
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Voriconazole-Induced QT Interval Prolongation: A Prospective Study
    Actual Study Start Date :
    Oct 31, 2016
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. QT interval prolongation [up to three months of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 20 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schneider childrens medical center of Isreal Petah Tikva Israel

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT04502355
    Other Study ID Numbers:
    • 0483-16-RMC
    First Posted:
    Aug 6, 2020
    Last Update Posted:
    Aug 6, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rabin Medical Center
    voriconazole, ECG, arrhythmia

    Study Results

    No Results Posted as of Aug 6, 2020