PMID- 22404732
OWN - NLM
STAT- MEDLINE
DCOM- 20121009
LR  - 20211021
IS  - 1469-0691 (Electronic)
IS  - 1198-743X (Print)
IS  - 1198-743X (Linking)
VI  - 18
IP  - 7
DP  - 2012 Jul
TI  - Anidulafungin for the treatment of candidaemia/invasive candidiasis in selected 
      critically ill patients.
PG  - 680-7
LID - 10.1111/j.1469-0691.2012.03784.x [doi]
AB  - A prospective, multicentre, phase IIIb study with an exploratory, open-label 
      design was conducted to evaluate efficacy and safety of anidulafungin for the 
      treatment of candidaemia/invasive candidiasis (C/IC) in specific ICU patient 
      populations. Adult ICU patients with confirmed C/IC meeting >/= 1 of the following 
      criteria were enrolled: post-abdominal surgery, solid tumour, renal/hepatic 
      insufficiency, solid organ transplant, neutropaenia, and age >/= 65 years. Patients 
      received anidulafungin (200 mg on day 1, 100 mg/day thereafter) for 10-42 days, 
      optionally followed by oral voriconazole/fluconazole. The primary efficacy 
      endpoint was global (clinical and microbiological) response at the end of all 
      therapy (EOT). Secondary endpoints included global response at the end of 
      intravenous therapy (EOIVT) and at 2 and 6 weeks post-EOT, survival at day 90, 
      and incidence of adverse events (AEs). The primary efficacy analysis was 
      performed in the modified intent-to-treat (MITT) population, excluding 
      unknown/missing responses. The safety and MITT populations consisted of 216 and 
      170 patients, respectively. The most common pathogens were Candida albicans 
      (55.9%), C. glabrata (14.7%) and C. parapsilosis (10.0%). Global success was 
      69.5% (107/154; 95% CI, 61.6-76.6) at EOT, 70.7% (111/157) at EOIVT, 60.2% 
      (77/128) at 2 weeks post-EOT, and 50.5% (55/109) at 6 weeks post-EOT. When 
      unknown/missing responses were included as failures, the respective success rates 
      were 62.9%, 65.3%, 45.3% and 32.4%. Survival at day 90 was 53.8%. 
      Treatment-related AEs occurred in 33/216 (15.3%) patients, four (1.9%) of whom 
      had serious AEs. Anidulafungin was effective, safe and well tolerated for the 
      treatment of C/IC in selected groups of ICU patients.
CI  - (c) 2012 Pfizer Inc. Clinical Microbiology and Infection (c) 2012 European Society of 
      Clinical Microbiology and Infectious Diseases.
FAU - Ruhnke, M
AU  - Ruhnke M
AD  - Department of Medicine, Charite University Hospital, Berlin, Germany. 
      markus.ruhnke@charite.de
FAU - Paiva, J A
AU  - Paiva JA
FAU - Meersseman, W
AU  - Meersseman W
FAU - Pachl, J
AU  - Pachl J
FAU - Grigoras, I
AU  - Grigoras I
FAU - Sganga, G
AU  - Sganga G
FAU - Menichetti, F
AU  - Menichetti F
FAU - Montravers, P
AU  - Montravers P
FAU - Auzinger, G
AU  - Auzinger G
FAU - Dimopoulos, G
AU  - Dimopoulos G
FAU - Borges Sa, M
AU  - Borges Sa M
FAU - Miller, P J
AU  - Miller PJ
FAU - Marcek, T
AU  - Marcek T
FAU - Kantecki, M
AU  - Kantecki M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20120308
PL  - England
TA  - Clin Microbiol Infect
JT  - Clinical microbiology and infection : the official publication of the European 
      Society of Clinical Microbiology and Infectious Diseases
JID - 9516420
RN  - 0 (Antifungal Agents)
RN  - 0 (Echinocandins)
RN  - 0 (Pyrimidines)
RN  - 0 (Triazoles)
RN  - 8VZV102JFY (Fluconazole)
RN  - 9HLM53094I (Anidulafungin)
RN  - JFU09I87TR (Voriconazole)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anidulafungin
MH  - Antifungal Agents/*adverse effects/*therapeutic use
MH  - Candida/classification/isolation & purification
MH  - Candidiasis, Invasive/*drug therapy
MH  - Critical Illness
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Echinocandins/*administration & dosage/*adverse effects
MH  - Female
MH  - Fluconazole/administration & dosage/adverse effects
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Pyrimidines/administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Triazoles/administration & dosage/adverse effects
MH  - Voriconazole
PMC - PMC3510306
EDAT- 2012/03/13 06:00
MHDA- 2012/10/10 06:00
CRDT- 2012/03/13 06:00
PHST- 2012/03/13 06:00 [entrez]
PHST- 2012/03/13 06:00 [pubmed]
PHST- 2012/10/10 06:00 [medline]
AID - S1198-743X(14)64567-5 [pii]
AID - 10.1111/j.1469-0691.2012.03784.x [doi]
PST - ppublish
SO  - Clin Microbiol Infect. 2012 Jul;18(7):680-7. doi: 
      10.1111/j.1469-0691.2012.03784.x. Epub 2012 Mar 8.