Efficacy of a new pharmacokinetically enhanced formulation of
amoxicillin/clavulanate (2000/125 mg) in adults with community-acquired pneumonia
caused by Streptococcus pneumoniae, including penicillin-resistant strains.
Author(s): File TM, Garau J, Jacobs MR, Wynne B, Twynholm M, Berkowitz E.
Affiliation(s): Summa Health System, 75 Arch Street, Akron, OH 44304, USA. filet@summa-health.org
Publication date & source: 2005, Int J Antimicrob Agents. , 25(2):110-9
Community-acquired pneumonia (CAP) is a common respiratory illness, frequently
caused by Streptococcus pneumoniae. The prevalence of S. pneumoniae resistance to
common antimicrobials has increased over recent years. A new pharmacokinetically
enhanced formulation of amoxicillin/clavulanate (2000/125 mg) has been developed,
designed to combat infections caused by S. pneumoniae, including
penicillin-resistant (PRSP, penicillin minimum inhibitory concentrations (MICs)
>or=2mg/l) isolates, and those with elevated amoxicillin/clavulanic acid MICs,
while maintaining coverage of beta-lactamase-producing pathogens. A pooled
efficacy analysis of four randomized (1:1) and one non-comparative clinical
trials of amoxicillin/clavulanate, 2000/125 mg, given twice daily, was conducted
in adult patients with CAP. Comparator agents were conventional
amoxicillin/clavulanate formulations. At follow-up (days 16-39), efficacy
(eradication of the initial pathogen or clinical cure in patients for whom no
repeat culture was performed) in patients with S. pneumoniae infection was 92.3%
(274/297) for amoxicillin/clavulanate, 2000/125 mg and 85.2% (46/54) for
comparators (P=0.11). Twenty-four of 25 PRSP-infected patients receiving
amoxicillin/clavulanate, 2000/125 mg were treated successfully. Both
amoxicillin/clavulanate, 2000/125 mg and comparators were well tolerated, with
few patients withdrawing from the studies.
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