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Published on: May 27, 2011
Voriconazole as primary antifungal prophylaxis in children undergoing allo-SCT
J R Molina1, J Serrano, J Sánchez-García
1Department of Hematology, Bone Marrow Transplantation Unit, and Instituto Maimonides Investigación Biomédica (IMIBIC), University Hospital Reina Sofia, Cordoba, Spain. josehristomoli@yahoo.es
Insights
Voriconazole effectively prevents invasive fungal disease in children undergoing stem cell transplants. This antifungal prophylaxis demonstrated safety and efficacy, with most patients completing treatment without IFD or significant adverse events.
Area of Science:
- Pediatric Hematology/Oncology
- Infectious Diseases
- Transplantation Medicine
Background:
- Invasive fungal disease (IFD) poses a significant risk of morbidity and mortality in pediatric patients post-allogeneic stem cell transplant (allo-SCT).
- Effective antifungal prophylaxis is crucial to improve outcomes in this vulnerable population.
Purpose of the Study:
- To evaluate the safety and efficacy of voriconazole as a primary antifungal prophylaxis in children undergoing allo-SCT.
- To compare two different dosing regimens of voriconazole in this pediatric cohort.
Main Methods:
- A prospective pilot study involving 56 children (<18 years) undergoing allo-SCT.
- Patients received voriconazole prophylaxis at 5 mg/kg or 7 mg/kg every 12 hours from day -1 to at least day +75 post-transplant.
- Follow-up for IFD and adverse events was conducted for 6 months post-transplant.
Main Results:
- 66.1% of patients completed voriconazole prophylaxis without IFD, empirical/preemptive antifungal therapy, or significant adverse effects.
- 16.1% of children required additional antifungal therapy, and 1.8% developed fatal probable IFD.
- 17.8% experienced voriconazole-related adverse effects, most commonly elevated hepatic enzymes, leading to withdrawal in some cases.
- No significant differences in efficacy or safety were observed between the 5 mg/kg and 7 mg/kg dosing groups.
Conclusions:
- Voriconazole can be safely and effectively utilized as primary antifungal prophylaxis in pediatric patients undergoing allo-SCT.
- The observed adverse effect profile and efficacy support the use of voriconazole in this high-risk population.
Abstract:
Invasive fungal disease (IFD) causes significant morbidity and mortality among children undergoing allo-SCT. In this prospective pilot study, we analyze voriconazole as primary antifungal prophylaxis. From October 2004 to July 2010, 56 children <18 years of age were enrolled in this study. Patients received voriconazole doses of 5 mg/kg per 12 h (n=23) or 7 mg/kg per 12 h (n=33), with a limiting dose of 200 mg/12 h, from day -1 to day +75 or later in patients with active acute GVHD. Patients were followed up for IFD for 6 months. In this series, 37 (66.1%) patients successfully completed treatment (85.7% during neutropenic period) without empirical or preemptive antifungal therapy, adverse effects or IFD. Nine (16.1%) children needed preemptive (n=2) or empirical (n=7) antifungal therapy, and one (1.8%) of them developed a fatal probable IFD during the study period. A total of 10 (17.8%) children developed adverse effects related to voriconazole prophylaxis, leading to definitive withdrawal on median day 26.5 (in 7 patients after granulocytic recovery). The most frequent adverse effect was persistent elevation of hepatic enzymes in seven (12.5%) children. There were no differences between doses of 5 and 7 mg/kg per 12 h. Our results suggest that voriconazole can be safely used as primary antifungal prophylaxis in children undergoing allo-SCT.
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