Document Detail


Efficacy and safety of linezolid compared with vancomycin in a randomized, double-blind study of febrile neutropenic patients with cancer.
MedLine Citation:
PMID:  16447103     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Gram-positive pathogens can cause serious infections in neutropenic patients with cancer, and vancomycin therapy is often initiated empirically. Linezolid may offer an option for these patients. METHODS: To compare the safety and efficacy of linezolid and vancomycin in febrile, neutropenic patients with cancer, we conducted a double-blind, multicenter equivalence study. Eligible patients with proven or suspected infection due to a gram-positive pathogen were randomized to receive linezolid or vancomycin. RESULTS: Clinical success rates 7 days after completion of therapy (primary end point) were equivalent between groups in the intent-to-treat (ITT) analysis (linezolid, 219 [87.3%] of 251 patients; vancomycin, 202 [85.2%] of 237 patients; 95% CI, -4.1 to 8.1; P=.52), modified ITT analysis, clinically evaluable analysis, and microbiologically evaluable analysis, as well as between subsets analyzed by malignancy and infection type. Mean time to defervescence was shorter for linezolid than vancomycin in the modified ITT (6.6 vs. 8.5 days; P=.04) and microbiologically evaluable subsets (5.9 vs. 9.1 days; P=.01), although post hoc analyses revealed delayed recovery of absolute neutrophil counts for linezolid in these subsets (P<.05). There were no between-group differences in microbiologic success rates in the modified ITT subset (41 [57.7%] of 71 patients vs. 29 [50.0%] of 58 patients; P=.38) and microbiologically evaluable subsets, as well as in mortality rates in the ITT subset (17 [5.6%] of 304 patients vs. 23 [7.6%] of 301 patients; P=.31) and all subsets. Distribution of adverse events, including reported hematologic events, was similar between groups, except that linezolid was associated with fewer drug-related adverse events (52 [17.2%] of 303 patients vs. 72 [24.0%] of 300 patients; P=.04) and fewer cases of drug-related renal failure (1 [0.3%] of 303 patients vs. 7 [2.3%] of patients; P=.04). CONCLUSIONS: Linezolid demonstrated efficacy and similar safety outcomes equivalent to those for vancomycin in febrile neutropenic patients with cancer.
Authors:
Branimir Jaksic; Giovanni Martinelli; Jaime Perez-Oteyza; Charlotte S Hartman; Linda B Leonard; Kenneth J Tack
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-01-25
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  42     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2006 Mar 
Date Detail:
Created Date:  2006-01-31     Completed Date:  2006-10-16     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  597-607     Citation Subset:  IM    
Affiliation:
Department of Medicine, Merkur University Hospital, Zagreb, Croatia. branimir.jaksic@zg.htnet.hr
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MeSH Terms
Descriptor/Qualifier:
Acetamides / adverse effects,  therapeutic use*
Adolescent
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents / adverse effects,  therapeutic use
Double-Blind Method
Female
Fever / complications,  drug therapy
Gram-Positive Bacterial Infections / complications*,  drug therapy*
Humans
Male
Middle Aged
Neoplasms / complications*
Neutropenia / complications*
Oxazolidinones / adverse effects,  therapeutic use*
Vancomycin / adverse effects,  therapeutic use*
Chemical
Reg. No./Substance:
0/Acetamides; 0/Anti-Bacterial Agents; 0/Oxazolidinones; 1404-90-6/Vancomycin; 165800-03-3/linezolid
Comments/Corrections
Comment In:
Clin Infect Dis. 2006 Jun 15;42(12):1813-4; author reply 1814-5   [PMID:  16705599 ]

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


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