Document Detail

Clinafloxacin monotherapy (CI-960) versus ceftazidime plus amikacin for empirical treatment of febrile neutropenic cancer patients.
MedLine Citation:
PMID:  11906496     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To assess the efficacy and safety of clinafloxacin as a single agent for the empirical treatment of febrile episodes and bacterial infections in neutropenic cancer patients. METHODS: An open label, active-controlled, randomized, parallel treatment, multicenter study was conducted where clinafloxacin monotherapy was compared to the combination of ceftazidime plus amikacin (plus optional vancomycin or teicoplanin). Four hundred and nineteen patients were randomized to receive either intravenous clinafloxacin 200 mg every 12 h or intravenous ceftazidime (2 g) iv every 8 h plus intravenous amikacin (15 mg/kg) per day in divided doses. All randomized patients were to receive a minimum of 48 h of primary study drug treatment, after which the primary treatment could be modified. Clinical and microbiological responses were evaluated at 7-21 days post-treatment after study treatment and long term (maximum 28 days), in intent-to-treat and modified intent-to-treat populations. RESULTS: Clinafloxacin and ceftazidime-amikacin were statistically equivalent for the 72-h defervescence rate, overall defervescence rate, time to defervescence, clinical success rate, by-pathogen microbiological eradication rate, and survival rate. Clinical cure was achieved in 84% (59/70) of patients who received clinafloxacin monotherapy. There were no significant differences between treatments in rates of adverse events or treatment discontinuation rates due to adverse events. CONCLUSIONS: Clinafloxacin appears to be an appropriate agent for empirical treatment in febrile neutropenic cancer patients.
M P Glauser; U Brennscheidt; O Cornely; A Grigg; A Figuera; C Keyserling; U Trostmann; L Welling; K Tack
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases     Volume:  8     ISSN:  1198-743X     ISO Abbreviation:  Clin. Microbiol. Infect.     Publication Date:  2002 Jan 
Date Detail:
Created Date:  2002-03-21     Completed Date:  2002-05-15     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9516420     Medline TA:  Clin Microbiol Infect     Country:  France    
Other Details:
Languages:  eng     Pagination:  14-25     Citation Subset:  IM    
CHUV-Center Hospitalier Universitaire Vaudois, Département de Médecine Interne, Division des Maladies Infectieuses, CHUV, Lausanne, Switzerland.
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MeSH Terms
Amikacin / adverse effects,  therapeutic use*
Anti-Bacterial Agents / adverse effects,  therapeutic use
Anti-Infective Agents / adverse effects,  therapeutic use*
Bacterial Infections / drug therapy*,  etiology
Ceftazidime / adverse effects,  therapeutic use*
Cephalosporins / adverse effects,  therapeutic use
Drug Resistance, Bacterial
Drug Therapy, Combination / adverse effects
Fever / drug therapy,  etiology
Middle Aged
Neoplasms / complications*
Neutropenia / drug therapy*,  etiology
Teicoplanin / adverse effects,  therapeutic use
Treatment Outcome
Vancomycin / adverse effects,  therapeutic use
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Anti-Infective Agents; 0/Cephalosporins; 0/Fluoroquinolones; 105956-97-6/clinafloxacin; 1404-90-6/Vancomycin; 37517-28-5/Amikacin; 61036-62-2/Teicoplanin; 78439-06-2/Ceftazidime

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

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