Voriconazole-Induced QT Interval Prolongation: A Prospective Study

• Conditions: Voriconazole Induced QT Interval Prolongation

• Registration Number: NCT04502355
• Lead Sponsor: Rabin Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-31
• Status Verified: 2020-08
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
QT interval prolongation	up to three months of treatment

Trial Locations

Locations (1)

Schneider childrens medical center of Isreal; 🇮🇱 Petah Tikva, Israel