PMID- 25000455 OWN - NLM STAT- MEDLINE DCOM- 20150924 LR - 20211021 IS - 1476-5365 (Electronic) IS - 0268-3369 (Linking) VI - 49 IP - 9 DP - 2014 Sep TI - Efficacy and safety of micafungin for the prophylaxis of invasive fungal infection during neutropenia in children and adolescents undergoing allogeneic hematopoietic SCT. PG - 1212-6 LID - 10.1038/bmt.2014.136 [doi] AB - 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. FAU - Park, H J AU - Park HJ AD - Center for Pediatric Oncology, National Cancer Center, Goyang-si, Republic of Korea. FAU - Park, M AU - Park M AD - Department of Pediatrics, Chungbuk National University College of Medicine, Cheongju, Republic of Korea. FAU - Han, M AU - Han M AD - Clinical Research Center, National Cancer Center, Goyang-si, Republic of Korea. FAU - Nam, B H AU - Nam BH AD - Clinical Research Center, National Cancer Center, Goyang-si, Republic of Korea. FAU - Koh, K N AU - Koh KN AD - Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea. FAU - Im, H J AU - Im HJ AD - Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea. FAU - Lee, J W AU - Lee JW AD - Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. FAU - Chung, N-G AU - Chung NG AD - Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. FAU - Cho, B AU - Cho B AD - Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. FAU - Kim, H-K AU - Kim HK AD - Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. FAU - Yoo, K H AU - Yoo KH AD - Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. FAU - Koo, H H AU - Koo HH AD - Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. FAU - Kang, H J AU - Kang HJ AD - Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea. FAU - Shin, H Y AU - Shin HY AD - Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea. FAU - Ahn, H S AU - Ahn HS AD - Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea. FAU - Lim, Y T AU - Lim YT AD - Department of Pediatrics, Pusan National University College of Medicine, Busan, Republic of Korea. FAU - Kook, H AU - Kook H AD - Department of Pediatrics, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea. FAU - Lyu, C J AU - Lyu CJ AD - Department of Pediatrics, Yonsei University, College of Medicine, Seoul, Republic of Korea. FAU - Hah, J O AU - Hah JO AD - Department of Pediatrics, Yeungnam University College of Medicine, Daegu, Republic of Korea. FAU - Park, J E AU - Park JE AD - Department of Pediatrics, Ajou University School of Medicine, Suwon, Republic of Korea. FAU - Lim, Y J AU - Lim YJ AD - Department of Pediatrics, Chungnam National University School of Medicine, Daejon, Republic of Korea. FAU - Seo, J J AU - Seo JJ AD - Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20140707 PL - England TA - Bone Marrow Transplant JT - Bone marrow transplantation JID - 8702459 RN - 0 (Antifungal Agents) RN - 0 (Echinocandins) RN - 0 (Lipopeptides) RN - R10H71BSWG (Micafungin) SB - IM MH - Adolescent MH - Adult MH - Antifungal Agents/adverse effects/*therapeutic use MH - Child MH - Child, Preschool MH - Echinocandins/adverse effects/*therapeutic use MH - Female MH - Hematopoietic Stem Cell Transplantation/*methods MH - Humans MH - Infant MH - Infant, Newborn MH - Lipopeptides/adverse effects/*therapeutic use MH - Male MH - Micafungin MH - Neutropenia/*microbiology MH - Prospective Studies MH - Transplantation Conditioning/methods MH - Treatment Outcome MH - Young Adult EDAT- 2014/07/08 06:00 MHDA- 2015/09/25 06:00 CRDT- 2014/07/08 06:00 PHST- 2013/12/31 00:00 [received] PHST- 2014/05/12 00:00 [revised] PHST- 2014/05/18 00:00 [accepted] PHST- 2014/07/08 06:00 [entrez] PHST- 2014/07/08 06:00 [pubmed] PHST- 2015/09/25 06:00 [medline] AID - bmt2014136 [pii] AID - 10.1038/bmt.2014.136 [doi] PST - ppublish SO - Bone Marrow Transplant. 2014 Sep;49(9):1212-6. doi: 10.1038/bmt.2014.136. Epub 2014 Jul 7.