Cefprozil versus high-dose amoxicillin/clavulanate in children with acute otitis media

Background: The recommendation of the Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group that high-dose amoxicillin, with or without clavulanate, be used to treat acute otitis media (AOM) addressed concerns about the efficacy of existing therapies against drug-resistant S pneumoniae....

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Bibliographic Details
Published in:Clinical therapeutics 2001-02, Vol.23 (2), p.193-204
Main Authors: Hedrick, James A., Sher, Lawrence D., Schwartz, Richard H., Pierce, Phillip
Format: Article
Language:English
Subjects:
Acute Disease
acute otitis media
Amoxicillin-Potassium Clavulanate Combination - therapeutic use
amoxicillin/clavulanate
Anti-Bacterial Agents - therapeutic use
Antibacterial agents
Antibiotics. Antiinfectious agents. Antiparasitic agents
Biological and medical sciences
Cefprozil
Cephalosporins - therapeutic use
Child
Child, Preschool
Drug Therapy, Combination - therapeutic use
Drug Tolerance
Female
Humans
Infant
Male
Medical sciences
Otitis Media - drug therapy
Pharmacology. Drug treatments
Single-Blind Method
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Summary:Background: The recommendation of the Drug-Resistant Streptococcus pneumoniae Therapeutic Working Group that high-dose amoxicillin, with or without clavulanate, be used to treat acute otitis media (AOM) addressed concerns about the efficacy of existing therapies against drug-resistant S pneumoniae. This recommendation relied on pharmaco-dynamic predictions of concentrations of amoxicillin in middle-ear fluid remaining higher than minimum inhibitory concentrations against intermediately resistant S pneumoniae for > 40% of the dosing interval. Objective: This study compared the tolerability and efficacy of cefprozil and high-dose amoxicillin/clavulanate in patients with AOM. Methods: Patients were randomized to receive 10 days of investigator-blinded oral treatment with either cefprozil suspension (30 mg/kg/d in 2 divided doses) or amoxicillin/clavulanate (45/6.4 mg/kg/d) plus amoxicillin (45 mg/kg/d) in 2 divided doses. The primary efficacy end point was the clinical cure rate 4 to 7 days after the end of treatment. Clinical response by age (6 months-
ISSN:0149-2918
1879-114X
DOI:10.1016/S0149-2918(01)80002-3