Document Detail

Effectiveness of short-course therapy (5 days) with cefuroxime axetil in treatment of secondary bacterial infections of acute bronchitis.
MedLine Citation:
PMID:  8585739     Owner:  NLM     Status:  MEDLINE    
Five hundred thirty-seven patients were enrolled in two independent, investigator-blinded, multicenter, randomized clinical trials comparing the clinical and bacteriologic efficacies and the safety of 5- or 10-day treatment with cefuroxime axetil with those of 10-day treatment with amoxicillin-clavulanate in the treatment of secondary bacterial infections of acute bronchitis. Patients received either 5 or 10 days of treatment (n = 177 in each group) with cefuroxime axetil at 250 mg twice daily or 10 days of treatment (n = 183) with amoxicillin-clavulanate at 500 mg three times daily. Patients in the cefuroxime axetil (5 days) group received placebo on days 6 to 10. Bacteriologic assessments were based on sputum specimen cultures obtained preceding and, when possible, following treatment. Organisms were isolated from the pretreatment sputum specimens of 242 of 537 (45%) patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureus (28, 25, 13, 9, and 8% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 87% (52 of 60), 91% (53 of 58), and 86% (60 of 70) of bacteriologically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. A satisfactory clinical outcome (cure or improvement) was achieved in 82% (107 of 130), 86% (117 of 136), and 83% (130 of 157) of the clinically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. Treatment with amoxicillin-clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil for either 5 or 10 days (P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37 versus 19 and 15%, respectively; P < 0.001), particularly diarrhea and nausea. These results indicate that treatment with cefuroxime axetil at 250 mg twice daily for 5 days is as effective as treatment for 10 days with either the same dose of cefuroxime axetil or amoxicillin-clavulanate at 500 mg three times daily in patients with acute bronchitis. In addition, treatment with cefuroxime axetil for either 5 or 10 days is associated with significantly fewer gastrointestinal adverse events, particularly diarrhea and nausea, than is 10-day treatment with amoxicillin-clavulanate.
D Henry; G E Ruoff; J Rhudy; A Puopolo; M Drehobl; J Schoenberger; G Giguere; J J Collins
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  39     ISSN:  0066-4804     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  1995 Nov 
Date Detail:
Created Date:  1996-03-20     Completed Date:  1996-03-20     Revised Date:  2009-11-18    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  2528-34     Citation Subset:  IM    
Foothill Family Clinic, Salt Lake City, Utah, USA.
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MeSH Terms
Acute Disease
Aged, 80 and over
Amoxicillin / adverse effects,  therapeutic use
Amoxicillin-Potassium Clavulanate Combination
Bacterial Infections / drug therapy*,  microbiology
Bronchitis / drug therapy*,  microbiology
Cefuroxime / administration & dosage,  adverse effects,  analogs & derivatives*,  therapeutic use
Cephalosporins / administration & dosage*,  adverse effects,  therapeutic use
Clavulanic Acids / adverse effects,  therapeutic use
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination / adverse effects,  therapeutic use
Middle Aged
Prospective Studies
Treatment Outcome
Reg. No./Substance:
0/Cephalosporins; 0/Clavulanic Acids; 26787-78-0/Amoxicillin; 55268-75-2/Cefuroxime; 64544-07-6/cefuroxime axetil; 74469-00-4/Amoxicillin-Potassium Clavulanate Combination

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

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