| Effectiveness of short-course therapy (5 days) with cefuroxime axetil in treatment of secondary bacterial infections of acute bronchitis. | |
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MedLine Citation:
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PMID: 8585739 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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D Henry; G E Ruoff; J Rhudy; A Puopolo; M Drehobl; J Schoenberger; G Giguere; J J Collins |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Antimicrobial agents and chemotherapy Volume: 39 ISSN: 0066-4804 ISO Abbreviation: Antimicrob. Agents Chemother. Publication Date: 1995 Nov |
Date Detail:
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Created Date: 1996-03-20 Completed Date: 1996-03-20 Revised Date: 2009-11-18 |
Medline Journal Info:
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Nlm Unique ID: 0315061 Medline TA: Antimicrob Agents Chemother Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 2528-34 Citation Subset: IM |
Affiliation:
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Foothill Family Clinic, Salt Lake City, Utah, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acute Disease Adolescent Adult Aged 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 Child Clavulanic Acids / adverse effects, therapeutic use Double-Blind Method Drug Administration Schedule Drug Therapy, Combination / adverse effects, therapeutic use Female Humans Male Middle Aged Prospective Studies Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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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 |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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