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Infections

Efficacy and safety of micafungin for the prophylaxis of invasive fungal infection during neutropenia in children and adolescents undergoing allogeneic hematopoietic SCT

Bone Marrow Transplantation volume 49, pages 1212–1216 (2014)Cite this article

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Abstract

The objective of this study was to evaluate the efficacy and safety of micafungin for the prevention of invasive fungal infection (IFI) during the neutropenic phase of allogeneic hematopoietic SCT (allo-HSCT) in children and adolescents. This was a prospective, multicenter, open-label, single-arm study. Micafungin was administered i.v. at a dose of 1 mg/kg/day (max 50 mg) from the beginning of conditioning until neutrophil engraftment. Treatment success was defined as the absence of proven, probable, possible or suspected IFI through to 4 weeks after therapy. From April 2010 to December 2011, 155 patients were enrolled from 11 institutions in Korea, and 147 patients were analyzed. Of the 147 patients, 121 (82.3%) completed the protocol without premature interruption. Of the 132 patients in whom micafungin efficacy could be evaluated, treatment success was achieved in 119 patients (90.2%). There was no proven fungal infection in any patient. The number of patients with probable, possible and suspected IFI was two, two and nine, respectively. Thirty-five patients (23.8%) experienced 109 adverse events (AEs) possibly related to micafungin. No patients experienced grade IV AEs. Two patients (1.4%) discontinued micafungin administration due to adverse effects. None of the deaths were related to the study drug.

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Acknowledgements

This study was coordinated by the Clinical Research Coordination Center, National Cancer Center, Korea, using the web-based clinical research management platform (Velos).

AUTHOR CONTRIBUTIONS

HJP designed the study, collected the data, performed analysis and reviewed the manuscript; MP performed the analysis and wrote the paper; JJS designed the study and reviewed the manuscript; MH collected the data and performed the analysis; BHN performed the anlaysis; KNK, HJI, JWL, N-GC, BC, H-KK, KHY, HHK, HJK, HYS, HSA, YTL, HK, CJL, JOH contributed to data collection.

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Authors and Affiliations

  1. Center for Pediatric Oncology, National Cancer Center, Goyang-si, Republic of Korea,

    H J Park

  2. Department of Pediatrics, Chungbuk National University College of Medicine, Cheongju, Republic of Korea

    M Park

  3. Clinical Research Center, National Cancer Center, Goyang-si, Republic of Korea,

    M Han & B H Nam

  4. Department of Pediatrics, Asan Medical Center Children’s Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea,

    K N Koh, H J Im & J J Seo

  5. Department of Pediatrics, Seoul St Mary’s Hospital, The Catholic University of Korea, Seoul, Republic of Korea,

    J W Lee, N-G Chung, B Cho & H-K Kim

  6. Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea,

    K H Yoo & H H Koo

  7. Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea

    H J Kang, H Y Shin & H S Ahn

  8. Department of Pediatrics, Pusan National University College of Medicine, Busan, Republic of Korea

    Y T Lim

  9. Department of Pediatrics, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea,

    H Kook

  10. Department of Pediatrics, Yonsei University, College of Medicine, Seoul, Republic of Korea

    C J Lyu

  11. Department of Pediatrics, Yeungnam University College of Medicine, Daegu, Republic of Korea,

    J O Hah

  12. Department of Pediatrics, Ajou University School of Medicine, Suwon, Republic of Korea

    J E Park

  13. Department of Pediatrics, Chungnam National University School of Medicine, Daejon, Republic of Korea

    Y J Lim

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  1. H J Park
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  2. M Park
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  3. M Han
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  14. H Y Shin
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  15. H S Ahn
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  16. Y T Lim
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  17. H Kook
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  18. C J Lyu
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  19. J O Hah
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  20. J E Park
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  22. J J Seo
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Correspondence to J J Seo.

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Park, H., Park, M., Han, M. et al. Efficacy and safety of micafungin for the prophylaxis of invasive fungal infection during neutropenia in children and adolescents undergoing allogeneic hematopoietic SCT. Bone Marrow Transplant 49, 1212–1216 (2014). https://doi.org/10.1038/bmt.2014.136

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