Universität zu Köln

Johnson, Stuart, Louie, Thomas J., Gerding, Dale N., Cornely, Oliver A., Chasan-Taber, Scott, Fitts, David, Gelone, Steven P., Broom, Colin and Davidson, David M. (2014). Vancomycin, Metronidazole, or Tolevamer for Clostridium difficile Infection: Results From Two Multinational, Randomized, Controlled Trials. Clin. Infect. Dis., 59 (3). S. 345 - 355. CARY: OXFORD UNIV PRESS INC. ISSN 1537-6591

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Abstract

Background. Clostridium difficile infection (CDI) is a common complication of antibiotic therapy that is treated with antibiotics, contributing to ongoing disruption of the colonic microbiota and CDI recurrence. Two multinational trials were conducted to compare the efficacy of tolevamer, a nonantibiotic, toxin-binding polymer, with vancomycin and metronidazole. Methods. Patients with CDI were randomly assigned in a 2: 1: 1 ratio to oral tolevamer 9 g (loading dose) followed by 3 g every 8 hours for 14 days, vancomycin 125 mg every 6 hours for 10 days, or metronidazole 375 mg every 6 hours for 10 days. The primary endpoint was clinical success, defined as resolution of diarrhea and absence of severe abdominal discomfort for more than 2 consecutive days including day 10. Results. In a pooled analysis, 563 patients received tolevamer, 289 received metronidazole, and 266 received vancomycin. Clinical success of tolevamer was inferior to both metronidazole and vancomycin (P < .001), and metronidazole was inferior to vancomycin (P = .02; 44.2% [n = 534], 72.7% [n = 278], and 81.1% [n = 259], respectively). Clinical success in patients with severe CDI who received metronidazole was 66.3% compared with vancomycin, which was 78.5%. (P = .059). A post-hoc multivariate analysis that excluded tolevamer found 3 factors that were strongly associated with clinical success: vancomycin treatment, treatment-naive status, and mild or moderate CDI severity. Adverse events were similar among the treatment groups. Conclusions. Tolevamer was inferior to antibiotic treatment of CDI, and metronidazole was inferior to vancomycin.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Johnson, Stuart UNSPECIFIED UNSPECIFIED UNSPECIFIED Louie, Thomas J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerding, Dale N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chasan-Taber, Scott UNSPECIFIED UNSPECIFIED UNSPECIFIED Fitts, David UNSPECIFIED UNSPECIFIED UNSPECIFIED Gelone, Steven P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Broom, Colin UNSPECIFIED UNSPECIFIED UNSPECIFIED Davidson, David M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-432314
DOI:	10.1093/cid/ciu313
Journal or Publication Title:	Clin. Infect. Dis.
Volume:	59
Number:	3
Page Range:	S. 345 - 355
Date:	2014
Publisher:	OXFORD UNIV PRESS INC
Place of Publication:	CARY
ISSN:	1537-6591
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language NORTH-AMERICA; DIARRHEA; DISEASE; COLITIS; STRAIN; FIDAXOMICIN; GUIDELINES; HOSPITALS; MORTALITY; OUTBREAK Multiple languages Immunology; Infectious Diseases; Microbiology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/43231