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Therapeutic Drug Monitoring of Voriconazole in Children with Hematologic Malignancy and Invasive Fungal Infections:
Neha Sharad1, Gagandeep Singh1, Immaculata Xess1
1Department of Microbiology, AIIMS, New Delhi, India.
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.
Insights
Therapeutic drug monitoring (TDM) of voriconazole improved outcomes in children with hematologic malignancy and suspected fungal infections. TDM helps achieve optimal voriconazole serum levels for better patient management.
Area of Science:
- Pharmacology
- Pediatric Oncology
- Infectious Diseases
Background:
- Voriconazole, a triazole antifungal, exhibits non-linear pharmacokinetics and a narrow therapeutic index.
- Invasive fungal infections are a significant concern in immunocompromised pediatric patients, particularly those with hematologic malignancies.
- Monitoring voriconazole serum levels is crucial for optimizing efficacy and minimizing toxicity.
Purpose of the Study:
- To monitor voriconazole serum levels in pediatric patients with hematologic malignancy and suspected invasive fungal infections.
- To evaluate the impact of therapeutic drug monitoring (TDM) on voriconazole serum concentrations and clinical outcomes.
- To identify factors influencing voriconazole levels in this vulnerable population.
Main Methods:
- Prospective, randomized controlled trial involving 30 children with hematologic malignancies and suspected invasive fungal infections.
- Patients were randomized into two groups: one group underwent TDM, while the other did not.
- Voriconazole trough levels were determined using bioassay on the fifth day of treatment.
Main Results:
- A favorable outcome was observed in 86.7% of patients in the TDM group compared to 73.3% in the non-TDM group.
- Only 33.3% of children achieved voriconazole serum levels within the therapeutic range without dose adjustments.
- Children with acute myeloid leukemia (AML) tended to have lower voriconazole levels, while those with acute lymphoblastic leukemia (ALL) had normal to elevated levels.
Conclusions:
- Therapeutic drug monitoring (TDM) is recommended for all pediatric patients with hematologic malignancy receiving voriconazole.
- TDM facilitates dose adjustments to achieve therapeutic voriconazole serum levels, improving patient management.
- Specific malignancies, such as AML, may require closer monitoring due to a propensity for lower voriconazole levels.
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