Efficacy and safety of micafungin for the treatment of patients with proven or probable invasive aspergillosis: A non-comparative, multicenter, phase IV, open-label study.
|Abstract||Few studies have assessed the efficacy and safety of micafungin in patients with proven or probable invasive aspergillosis (IA). This was the aim of the current study, which was conducted in 22 hospitals in China, where micafungin was approved for treatment of IA in 2006.|
Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant.
|Publication Year Start||0-01-01|
PMID- 29384927 OWN - NLM STAT- In-Process LR - 20180131 IS - 1536-5964 (Electronic) IS - 0025-7974 (Linking) VI - 96 IP - 52 DP - 2017 Dec TI - Efficacy and safety of micafungin for the treatment of patients with proven or probable invasive aspergillosis: A non-comparative, multicenter, phase IV, open-label study. PG - e9443 LID - 10.1097/MD.0000000000009443 [doi] AB - INTRODUCTION: Few studies have assessed the efficacy and safety of micafungin in patients with proven or probable invasive aspergillosis (IA). This was the aim of the current study, which was conducted in 22 hospitals in China, where micafungin was approved for treatment of IA in 2006. METHODS: This was a non-comparative, phase IV open-label study (NCT02646774). Eligible patient were adults with proven or probable IA. Efficacy endpoints included rates of overall treatment success (primary endpoint) and clinical improvement, fungal clearance, mortality, and the site of Aspergillus infection (all secondary endpoints). Safety endpoints included incidences of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and adverse drug reactions (ADRs). These endpoints were reported descriptively with associated 95% confidence intervals (CI); no hypotheses were tested. RESULTS: The study was discontinued early due to low patient recruitment, which did not allow for the planned sample size to be reached. In total, 68 patients were enrolled: 42 into the full analysis set (for efficacy) and 61 into the safety analysis set. All patients were Han Chinese; the majority were male (n = 26; 61.9%) and </=60 years of age (n = 35; 83.3%). Rates of overall treatment success, clinical improvement, fungal clearance, and mortality were 45.2% (n = 19/42; 95% CI: 29.85-61.33); 59.5% (n = 25/42; 95% CI: 43.28-74.37), 80.0% (n = 4/5; 95% CI: 28.36-99.49), and 7.1% (n = 3/42; 95% CI: 1.50-19.48), respectively. All patients were diagnosed with pulmonary Aspergillus infection. Overall, 155 TEAEs and 8 SAEs were reported by 37 (60.7%) and 7 (11.5%) patients. The most common TEAEs were decreased platelet count and fatigue (both n = 5; 8.2%) and the most common SAEs were intracranial hemorrhage and lung infection (n = 3; 4.9% and n = 2; 3.3%). Eight ADRs (n = 6; 9.8%) were reported but all were completely remitted or remitting during follow-up. CONCLUSIONS: Results suggest that micafungin is efficacious and well-tolerated in patients with proven or probable IA in China. However, these findings should be interpreted with care, due to the small number of patients included in this study. Further comparative trials should be used to confirm the efficacy and safety of micafungin in patients with proven or probable IA. CI - Copyright (c) 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved. FAU - Ji, Yu AU - Ji Y AD - Beijing United Family Hospital. AD - Peking University People's Hospital, Beijing. FAU - Song, Yongping AU - Song Y AD - HeNan Cancer Hospital, Zhangzhou. AD - The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou. FAU - Zhou, Fang AU - Zhou F AD - General Hospital of Jinan Military Area, Jinan. FAU - Liu, Ting AU - Liu T AD - West China Hospital of Sichuan University, Chengdu. FAU - Jiang, Ming AU - Jiang M AD - The First Affiliated Hospital of Xinjiang Medical University, Urumqi. FAU - Zhao, Xielan AU - Zhao X AD - Xiangya Hospital, Central South University, Changsha, China. FAU - Huang, Xiaojun AU - Huang X AD - Peking University People's Hospital, Beijing. LA - eng PT - Journal Article PL - United States TA - Medicine (Baltimore) JT - Medicine JID - 2985248R EDAT- 2018/02/01 06:00 MHDA- 2018/02/01 06:00 CRDT- 2018/02/01 06:00 PHST- 2018/02/01 06:00 [entrez] PHST- 2018/02/01 06:00 [pubmed] PHST- 2018/02/01 06:00 [medline] AID - 10.1097/MD.0000000000009443 [doi] AID - 00005792-201712290-00035 [pii] PST - ppublish SO - Medicine (Baltimore). 2017 Dec;96(52):e9443. doi: 10.1097/MD.0000000000009443.