Anidulafungin for the treatment of candidaemia/invasive candidiasis in selected critically ill patients
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F12%3A43903526" target="_blank" >RIV/00216208:11120/12:43903526 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00064173:_____/12:43903526
Výsledek na webu
<a href="http://dx.doi.org/10.1111/j.1469-0691.2012.03784.x" target="_blank" >http://dx.doi.org/10.1111/j.1469-0691.2012.03784.x</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1111/j.1469-0691.2012.03784.x" target="_blank" >10.1111/j.1469-0691.2012.03784.x</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Anidulafungin for the treatment of candidaemia/invasive candidiasis in selected critically ill patients
Popis výsledku v původním jazyce
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. . 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%).
Název v anglickém jazyce
Anidulafungin for the treatment of candidaemia/invasive candidiasis in selected critically ill patients
Popis výsledku anglicky
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. . 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%).
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FN - Epidemiologie, infekční nemoci a klinická imunologie
OECD FORD obor
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Návaznosti výsledku
Projekt
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Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2012
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Clinical Microbiology and Infection
ISSN
1198-743X
e-ISSN
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Svazek periodika
18
Číslo periodika v rámci svazku
7
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
8
Strana od-do
680-687
Kód UT WoS článku
000305285200024
EID výsledku v databázi Scopus
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