Document Detail


Fidaxomicin versus vancomycin for Clostridium difficile infection.
MedLine Citation:
PMID:  21288078     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Clostridium difficile infection is a serious diarrheal illness associated with substantial morbidity and mortality. Patients generally have a response to oral vancomycin or metronidazole; however, the rate of recurrence is high. This phase 3 clinical trial compared the efficacy and safety of fidaxomicin with those of vancomycin in treating C. difficile infection.
METHODS: Adults with acute symptoms of C. difficile infection and a positive result on a stool toxin test were eligible for study entry. We randomly assigned patients to receive fidaxomicin (200 mg twice daily) or vancomycin (125 mg four times daily) orally for 10 days. The primary end point was clinical cure (resolution of symptoms and no need for further therapy for C. difficile infection as of the second day after the end of the course of therapy). The secondary end points were recurrence of C. difficile infection (diarrhea and a positive result on a stool toxin test within 4 weeks after treatment) and global cure (i.e., cure with no recurrence).
RESULTS: A total of 629 patients were enrolled, of whom 548 (87.1%) could be evaluated for the per-protocol analysis. The rates of clinical cure with fidaxomicin were noninferior to those with vancomycin in both the modified intention-to-treat analysis (88.2% with fidaxomicin and 85.8% with vancomycin) and the per-protocol analysis (92.1% and 89.8%, respectively). Significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence of the infection, in both the modified intention-to-treat analysis (15.4% vs. 25.3%, P=0.005) and the per-protocol analysis (13.3% vs. 24.0%, P=0.004). The lower rate of recurrence was seen in patients with non–North American Pulsed Field type 1 strains. The adverse-event profile was similar for the two therapies.
CONCLUSIONS: The rates of clinical cure after treatment with fidaxomicin were noninferior to those after treatment with vancomycin. Fidaxomicin was associated with a significantly lower rate of recurrence of C. difficile infection associated with non–North American Pulsed Field type 1 strains. (Funded by Optimer Pharmaceuticals; ClinicalTrials.gov number, NCT00314951.)
Authors:
Thomas J Louie; Mark A Miller; Kathleen M Mullane; Karl Weiss; Arnold Lentnek; Yoav Golan; Sherwood Gorbach; Pamela Sears; Youe-Kong Shue;
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  364     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-02-08     Completed Date:  2011-02-10     Revised Date:  2011-11-10    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  422-31     Citation Subset:  AIM; IM    
Affiliation:
University of Calgary, Calgary, AB, Canada. thomas.louie@albertahealthservices.ca
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aminoglycosides / adverse effects,  pharmacokinetics,  therapeutic use*
Anti-Bacterial Agents / adverse effects,  pharmacokinetics,  therapeutic use*
Clostridium Infections / drug therapy*
Clostridium difficile* / classification,  drug effects,  isolation & purification
Double-Blind Method
Enterocolitis, Pseudomembranous / drug therapy
Feces / microbiology
Female
Humans
Intention to Treat Analysis
Male
Microbial Sensitivity Tests
Middle Aged
Prospective Studies
Recurrence / prevention & control
Treatment Outcome
Vancomycin / adverse effects,  pharmacokinetics,  therapeutic use*
Chemical
Reg. No./Substance:
0/Aminoglycosides; 0/Anti-Bacterial Agents; 1404-90-6/Vancomycin; 56645-60-4/lipiarmycin
Comments/Corrections
Comment In:
Gastroenterology. 2011 Sep;141(3):1116-8   [PMID:  21801724 ]
N Engl J Med. 2011 May 12;364(19):1875; author reply 1875-6   [PMID:  21561361 ]
N Engl J Med. 2011 May 12;364(19):1875; author reply 1875-6   [PMID:  21561360 ]
N Engl J Med. 2011 Feb 3;364(5):473-5   [PMID:  21288079 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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