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PMID- 29384927
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.