JAC Advance Access originally published online on October 16, 2003
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Journal of Antimicrobial Chemotherapy (2003) 52, 826-836
© 2003 The British Society for Antimicrobial Chemotherapy
Oral pharmacokinetically enhanced co-amoxiclav 2000/125 mg, twice daily, compared with co-amoxiclav 875/125 mg, three times daily, in the treatment of community-acquired pneumonia in European adults
1 Department of Medicine, Hospital Mutua de Terrassa, Barcelona; 3 GlaxoSmithKline, Madrid; 4 Hospital Son Dureta, Palma de Mallorca; 5 Hospital Reina Sofía, Cordoba, Spain; 2 GlaxoSmithKline, Harlow, UK
Received 10 June 2003; returned 9 July 2003; revised 24 August 2003; accepted 26 August 2003
Objectives: Pharmacokinetically enhanced co-amoxiclav 2000/125 mg was designed to achieve high serum concentrations of amoxicillin over the 12 h dosing interval to eradicate Streptococcus pneumoniae with amoxicillin MICs of at least 4 mg/L.
Methods: This randomized, double-blind, double-dummy, multicentre study compared the efficacy and safety of oral co-amoxiclav 2000/125 mg twice daily versus co-amoxiclav 875/125 mg three times daily, for 7 or 10 days, in the treatment of community-acquired pneumonia (CAP).
Results: The per-protocol (PP) population at follow-up (Days 18–39) comprised 114 patients receiving co-amoxiclav 2000/125 mg and 116 receiving co-amoxiclav 875/125 mg. Clinical success at follow-up (primary efficacy endpoint) in the clinical PP population was 94.7% (108/114) for co-amoxiclav 2000/125 mg versus 88.8% (103/116) for co-amoxiclav 875/125 mg [treatment difference (TD) = 5.9%, 95% CI: 1.1, 13.0]. Bacteriological success in the bacteriology PP population at follow-up was 85.0% (17/20) for co-amoxiclav 2000/125 mg versus 77.3% (17/22) for co-amoxiclav 875/125 mg (TD = 7.7%, 95% CI: 15.8, 31.2). Penicillin-resistant S. pneumoniae (PRSP) were isolated in three patients (including two with bacteraemia) in the co-amoxiclav 2000/125 mg group (amoxicillin MICs 8 mg/L, penicillin MICs 4 mg/L) and one in the comparator group; all were clinical and bacteriological successes. Co-amoxiclav 2000/125 mg and co-amoxiclav 875/125 mg were associated with adverse events leading to withdrawal in 6.3% and 6.2% of patients, respectively.
Conclusions: Co-amoxiclav 2000/125 mg twice daily was at least as effective clinically as co-amoxiclav 875/125 mg three times daily in the treatment of CAP. Although few patients in this study had PRSP infection, 3/3 were successfully treated with co-amoxiclav 2000/125 mg.
Keywords: Streptococcus pneumoniae, CAP, antimicrobials
* Corresponding author. Tel: +34-93-785-7461; Fax: +34-93-736-5037; E-mail: jagarau{at}terra.es
Members of the 557 Clinical Study Group are listed in the Acknowledgements.
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