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Volume 12
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10.3390/children12040467
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Article

Real World Posaconazole Pharmacokinetic Data in Paediatric Stem Cell Transplant Recipients

by
Csaba Kassa
1,*,
Katalin Csordás
1,
Lídia Hau
1,
Orsolya Horváth
2,
Krisztián Kállay
1,
Gabriella Kertész
1,
Márton Kiss
3,
János Sinkó
4,
Ágnes Wolfort
5 and
Gergely Kriván
1
1
Department of Pediatric Hematology and Stem Cell Transplantation, National Institute of Hematology and Infectious Diseases, South-Pest Central Hospital, 1097 Budapest, Hungary
2
Pediatric Center, Semmelweis University, 1085 Budapest, Hungary
3
Independent Researcher, 1132 Budapest, Hungary
4
Heim Pál Children’s Hospital, 1089 Budapest, Hungary
5
Department of Hematology and Stem Cell Transplantation, National Institute of Hematology and Infectious Diseases, South-Pest Central Hospital, 1097 Budapest, Hungary
*
Author to whom correspondence should be addressed.
Children 2025, 12(4), 467; https://doi.org/10.3390/children12040467
Submission received: 27 February 2025 / Revised: 27 March 2025 / Accepted: 2 April 2025 / Published: 5 April 2025
(This article belongs to the Special Issue The Diagnosis and Management of Pediatric Leukemia)
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Abstract

Background: Invasive fungal disease is a significant cause of morbidity and mortality in allogeneic hematopoietic stem cell transplant (alloHSCT) recipients. Posaconazole, a broad-spectrum triazole, is widely used as prophylaxis. Methods: We conducted a monocentric, retrospective study to present real-world data on posaconazole trough levels in paediatric alloHSCT patients. The main objective was to determine the required daily dose of posaconazole in paediatric patients. We analysed factors influencing posaconazole levels, and the association between posaconazole levels and breakthrough fungal infection. Results: Among 102 allogeneic HSCT recipients, we measured posaconazole plasma concentrations in 548 blood samples. The required daily doses to reach a target range of 0.7–2.0 mg/L were 15.22 (suspension), 7.52 (tablet), and 7.84 mg/kg (intravenous). Patients aged < 13 years needed higher doses to achieve the target range. The presence of enteral symptoms during prophylaxis was associated with lower plasma concentrations (p < 0.001), while co-administration of proton pump inhibitors did not (p = 0.09). Eight breakthrough infections occurred; low levels of posaconazole (<0.7 mg/L) were observed in five out of eight cases. The Cox regression model showed that higher mean plasma concentrations decreased the hazard of breakthrough infections. Conclusions: The tablet and intravenous formulations of posaconazole outperformed the suspension in terms of predictability. Our analyses on breakthrough infections and posaconazole plasma levels suggest an exposure–response relationship.
Keywords: posaconazole; therapeutic drug monitoring; stem cell transplantation; paediatric; breakthrough infection posaconazole; therapeutic drug monitoring; stem cell transplantation; paediatric; breakthrough infection

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MDPI and ACS Style

Kassa, C.; Csordás, K.; Hau, L.; Horváth, O.; Kállay, K.; Kertész, G.; Kiss, M.; Sinkó, J.; Wolfort, Á.; Kriván, G. Real World Posaconazole Pharmacokinetic Data in Paediatric Stem Cell Transplant Recipients. Children 2025, 12, 467. https://doi.org/10.3390/children12040467

AMA Style

Kassa C, Csordás K, Hau L, Horváth O, Kállay K, Kertész G, Kiss M, Sinkó J, Wolfort Á, Kriván G. Real World Posaconazole Pharmacokinetic Data in Paediatric Stem Cell Transplant Recipients. Children. 2025; 12(4):467. https://doi.org/10.3390/children12040467

Chicago/Turabian Style

Kassa, Csaba, Katalin Csordás, Lídia Hau, Orsolya Horváth, Krisztián Kállay, Gabriella Kertész, Márton Kiss, János Sinkó, Ágnes Wolfort, and Gergely Kriván. 2025. "Real World Posaconazole Pharmacokinetic Data in Paediatric Stem Cell Transplant Recipients" Children 12, no. 4: 467. https://doi.org/10.3390/children12040467

APA Style

Kassa, C., Csordás, K., Hau, L., Horváth, O., Kállay, K., Kertész, G., Kiss, M., Sinkó, J., Wolfort, Á., & Kriván, G. (2025). Real World Posaconazole Pharmacokinetic Data in Paediatric Stem Cell Transplant Recipients. Children, 12(4), 467. https://doi.org/10.3390/children12040467

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