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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.

Abstract
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.
AuthorsThomas M File, Javier Garau, Michael R Jacobs, Brian Wynne, Monique Twynholm, Elchonon Berkowitz
JournalInternational journal of antimicrobial agents (Int J Antimicrob Agents) Vol. 25 Issue 2 Pg. 110-9 (Feb 2005) ISSN: 0924-8579 [Print] Netherlands
PMID15664480 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Bacterial Agents
  • Amoxicillin-Potassium Clavulanate Combination
Topics
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin-Potassium Clavulanate Combination (pharmacokinetics, pharmacology, therapeutic use)
  • Anti-Bacterial Agents (pharmacokinetics, pharmacology, therapeutic use)
  • Community-Acquired Infections (drug therapy, microbiology)
  • Double-Blind Method
  • Drug Resistance, Bacterial
  • Female
  • Humans
  • Male
  • Middle Aged
  • Penicillin Resistance
  • Pneumonia, Pneumococcal (drug therapy, microbiology)
  • Streptococcus pneumoniae (drug effects)
  • Treatment Outcome

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