Title:Therapeutic Drug Monitoring of Voriconazole in Children with Hematologic
Malignancy and Invasive Fungal Infections: An RCT from a Tertiary Care
Centre in India
Volume: 23
Issue: 4
Author(s): Neha Sharad, Gagandeep Singh*, Immaculata Xess, Reshu Agarwal, Tulika Seth, K.H. Reeta and Sweta Kothari
Affiliation:
- Department of Microbiology, AIIMS, New Delhi, India
Keywords:
Voriconazole, TDM, children, IFIs, hematologic malignancy, aspergillus.
Abstract:
Introduction: Voriconazole is a triazole anti-fungal with non-linear kinetics and a
narrow therapeutic range. The objective of our study was to monitor the voriconazole serum levels
in children with hematological malignancy and clinically suspected invasive fungal infections.
Methods: The study was a prospective, randomized controlled trial conducted from June 2016 to
December 2017. All children who had haematologic malignancies with clinically suspected invasive
fungal infections and received voriconazole as the only anti-fungal were included in the
study. The children were randomly allotted into two groups; one was the group that underwent
TDM, and the other, TDM, was not done. Bioassay was the method employed for TDM. The
trough levels were evaluated on a sample obtained on the fifth day of starting the drug. The institute's
ethics committee approved the study.
Result: A total of 30 children were included in the study: 15 in the TDM group and 15 in the
non-TDM group. The most common underlying malignancy was AML. Neutropenia due to
chemotherapy sessions was these patients' most common risk factor. A favorable outcome was
seen in 13/15 (86.7%) in the TDM group and 11/15 in the non-TDM group (73.3%).
Conclusion: Only five out of 15 (33.3%) children had voriconazole serum levels within the therapeutic
range. Alterations in dose had to be done in the remaining to achieve the recommended
serum levels. Thus, we recommend TDM for all children of hematologic malignancy receiving
voriconazole for better management. Our findings also revealed that children with AML had
lower than recommended levels of voriconazole on TDM evaluation, whereas those with ALL
had normal to elevated levels of voriconazole.
