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Voriconazole Antifungal Prophylaxis in Children With Malignancies: A Nationwide Study
Zoi Dorothea Pana1,2, Maria Kourti3, Katerina Vikelouda1
1Infectious Diseases Unit, 3rd Department of Pediatrics, Faculty of Medicine, Aristotle University School of Health Sciences.
Insights
Antifungal prophylaxis with voriconazole (VRC) is safe for pediatric hematology-oncology patients. This study found VRC well-tolerated with manageable adverse events, supporting its use in this vulnerable population.
Area of Science:
- Pediatric Hematology-Oncology
- Infectious Disease Prevention
- Pharmacovigilance
Background:
- Antifungal prophylaxis (AFP) is crucial for immunocompromised pediatric patients undergoing cancer treatment.
- Voriconazole (VRC) is a broad-spectrum antifungal agent used for prophylaxis.
- Evaluating VRC safety in pediatric hematology-oncology patients is essential.
Purpose of the Study:
- To assess the safety and tolerability of voriconazole (VRC) as antifungal prophylaxis (AFP) in pediatric patients with hematologic malignancies.
- To identify and characterize adverse events associated with VRC use in this population.
Main Methods:
- Retrospective study conducted across 7 Greek pediatric hematology-oncology centers (2008-2012).
- Inclusion of 249 pediatric patients (median age 6 years) receiving VRC AFP.
- Data collection on demographics, underlying diseases, VRC dosage, duration, and adverse events.
Main Results:
- 429 VRC AFP courses were analyzed; common diagnoses included acute lymphoblastic leukemia (51%).
- Most common adverse events were elevated liver enzymes (50% of AEs), hypokalemia (24.3%), and ophthalmological disorders (14.3%).
- Only one breakthrough fungemia and one death due to underlying disease were reported, indicating good overall outcomes.
Conclusions:
- Voriconazole (VRC) antifungal prophylaxis (AFP) is well-tolerated in pediatric hematology-oncology patients.
- The observed adverse events were generally mild to moderate and manageable.
- VRC represents a safe prophylactic option for this high-risk patient group.
Background:
Antifungal prophylaxis (AFP) is recommended in at-risk hematology-oncology patients. We evaluated the safety of AFP with voriconazole (VRC) in pediatric hematology/oncology patients.
Materials And Methods:
A retrospective study of VRC AFP in children with malignancies hospitalized in all 7 Greek pediatric hematology/oncology centers during 2008 to 2012 was conducted. Patients' demographics, outcome, and adverse event (AE) data were recorded.
Results:
Four hundred twenty-nine VRC AFP courses in 249 patients (median age 6 y, 55% boys) were studied. The most common underlying diseases were acute lymphoblastic leukemia (51%), non Hodgkin lymphoma (8.6%), and acute myeloid leukemia (7.7%). The median number of VRC courses per patient was 1.7, whereas the median VRC dose was 7 mg/kg (range, 5 to 7 mg/kg) every 12 hours. During the last 2 weeks before AFP, 51% of the patients had received corticosteroids, 43% suffered from severe neutropenia, and 17.3% from mucositis. The median duration of VRC AFP was 17 days (range, 1 to 31 d). A single breakthrough fungemia due to Candida glabrata was recorded. Only 1 patient died due to the underlying disease. The most common AEs reported in 70/429 (16.3%) courses with ≥1 AE were elevated liver enzymes (50%), hypokalemia (24.3%), and ophthalmological disorders (14.3%). The median time of AE onset was 5 days (range, 1 to 21 d). Among 70 AEs reported, 38.5%, 48.4%, and 12.8% were of grade I, II, and III, respectively.
Conclusions:
VRC prophylaxis in pediatric hematology/oncology patients appears to be well tolerated.
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