Universität zu Köln

Vehreschild, Maria J. G. T., Taori, Surabhi ORCID: 0000-0002-2976-4106, Goldenberg, Simon D., Thalhammer, Florian, Bouza, Emilio ORCID: 0000-0001-6967-9267, van Oene, Joop, Wetherill, Graham and Georgopali, Areti (2018). Fidaxomicin for the treatment of Clostridium difficile infection (CDI) in at-risk patients with inflammatory bowel disease, fulminant CDI, renal impairment or hepatic impairment: a retrospective study of routine clinical use (ANEMONE). Eur. J. Clin. Microbiol. Infect. Dis., 37 (11). S. 2097 - 2107. NEW YORK: SPRINGER. ISSN 1435-4373

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Abstract

Information is limited or lacking on fidaxomicin treatment of Clostridium difficile infection (CDI) in patients with inflammatory bowel disease, fulminant or life-threatening CDI, severe renal impairment, moderate-to-severe hepatic impairment and pregnancy. The ANEMONE study investigated fidaxomicin use in a routine clinical setting, focusing on these medical conditions of specific interest (MCSIs). This retrospective, post-authorisation study reviewed hospital records from Austria, Germany, Spain and the UK (June 2012-June 2015), collecting data from hospital admission to 30days after last fidaxomicin dose. The primary objective was to identify the proportion of fidaxomicin-treated patients with MCSIs. Secondary objectives were to describe 30-day mortality, changes in ECG and laboratory parameters, fidaxomicin exposure and CDI response (resolution of diarrhoea; 30-day recurrence). 45.3% (261/576) of patients had 1 MCSI. Thirty-day mortality (post-first dose) was 17.0% (98/576) in the total population and slightly higher (24.6-27.6%) in patients with fulminant CDI or severe renal impairment. 29.6% (24/81) deaths of known cause were attributable to CDI. Of changes in laboratory parameters or ECG findings, only a decrease in leucocyte counts appeared associated with fidaxomicin, consistent with a positive treatment response. Diarrhoea resolved in 78.0% (404/518) of treatment episodes; diarrhoea resolution was lowest in patients with fulminant CDI (investigator-defined, 67.5%, 56/88) and severe renal impairment (68.0%, 68/100). Thirty-day recurrence (18.8%, 79/420) was similar across MCSI subgroups. Although almost half of fidaxomicin-treated patients had 1 MCSI, the majority of patients in all subgroups had positive responses to treatment, and no particular safety concerns were identified.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Vehreschild, Maria J. G. T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Taori, Surabhi UNSPECIFIED orcid.org/0000-0002-2976-4106 UNSPECIFIED Goldenberg, Simon D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Thalhammer, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Bouza, Emilio UNSPECIFIED orcid.org/0000-0001-6967-9267 UNSPECIFIED van Oene, Joop UNSPECIFIED UNSPECIFIED UNSPECIFIED Wetherill, Graham UNSPECIFIED UNSPECIFIED UNSPECIFIED Georgopali, Areti UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-168062
DOI:	10.1007/s10096-018-3344-1
Journal or Publication Title:	Eur. J. Clin. Microbiol. Infect. Dis.
Volume:	37
Number:	11
Page Range:	S. 2097 - 2107
Date:	2018
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1435-4373
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language OUTCOMES; EPIDEMIOLOGY; PREVENTION; OPT-80 Multiple languages Infectious Diseases; Microbiology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16806