Abstract
In this double-blind study, 557 patients with lower respiratory tract infection were randomly assigned to receive amoxicillin/clavulanate orally either every 12 hours (875/125 mg) or every 8 hours (500/125 mg) for 7-15 days. For the 455 patients evaluable for clinical efficacy at the end of therapy, clinical success was similar in the two groups: 93% and 94% in the 12-hour and 8-hour groups, respectively (P = .42). Bacteriologic success at the end of therapy was also comparable: 97% and 91% in the 12-hour and 8-hour groups, respectively (P = .86). The occurrence of adverse events related to treatment was similar for the two groups, but fewer patients in the 12-hour group reported moderate or severe diarrhea. Amoxicillin/clavulanate (875/125 mg) given every 12 hours is as effective and safe as every-8-hours administration of the combination (500/125 mg) for the treatment of lower respiratory tract infection.
Publication types
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Clinical Trial
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Adult
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Aged
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Aged, 80 and over
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Amoxicillin / adverse effects
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Amoxicillin / therapeutic use*
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Anti-Bacterial Agents / adverse effects
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Anti-Bacterial Agents / therapeutic use*
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Bronchitis / drug therapy*
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Bronchitis / microbiology
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Clavulanic Acid
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Clavulanic Acids / adverse effects
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Clavulanic Acids / therapeutic use*
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Dose-Response Relationship, Drug
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Double-Blind Method
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Drug Therapy, Combination
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Female
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Humans
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International Cooperation
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Male
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Middle Aged
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Penicillins / adverse effects
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Penicillins / therapeutic use*
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Pneumonia, Bacterial / drug therapy*
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Pneumonia, Bacterial / microbiology
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Respiratory Tract Infections / drug therapy
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Respiratory Tract Infections / microbiology
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Time Factors
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Treatment Outcome
Substances
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Anti-Bacterial Agents
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Clavulanic Acids
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Penicillins
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Clavulanic Acid
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Amoxicillin