Voriconazole Induced QT Interval Prolongation Clinical Trial
Official title:
Voriconazole-Induced QT Interval Prolongation: A Prospective Study
| Verified date | August 2020 |
| Source | Rabin Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A to 20 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Schneider childrens medical center of Isreal | Petah Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | QT interval prolongation | up to three months of treatment |