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JAC Advance Access published online on January 30, 2006
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dki480
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© The Author 2006. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org
Received September 1, 2005
Revised November 23, 2005
Accepted December 12, 2005

Original article

Efficacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae

B. Siquier 1, J. Sánchez-Alvarez 2, E. García-Mendez 3, M. Sabriá 4, J. Santos 5, R. Pallarés 6, M. Twynholm 7, R. Dal-Ré 3 *, and on behalf of the 620 Clinical Study Group

1 Emergency Room, Hospital Son Dureta, Palma de Mallorca, Spain
2 Department of Internal Medicine, Hospital Virgen del Camino, Pamplona, Spain
3 Medical Department, GlaxoSmithKline, Tres Cantos, Spain
4 Infectious Diseases Unit, H. Germans Trias i Pujol, Badalona, Spain
5 Infectious Diseases Unit, Hospital Virgen de la Victoria, Málaga, Spain
6 Infectious Disease Service, Hospital Bellvitge, Barcelona, Spain
7 Antibiotics, Infectious Disease MDC, GlaxoSmithKline, Greenford, UK

* To whom correspondence should be addressed.
R. Dal-Ré, E-mail: rafael.dal-re{at}gsk.com


  Abstract

Objectives: This randomized, double-blind, non-inferiority trial evaluated the efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg twice daily versus amoxicillin/clavulanate 875/125 mg three times daily, both given orally for 7 or 10 days, in the treatment of adults with community-acquired pneumonia in Spain, a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae.

Patients and methods: Following 2:1 randomization, 566 patients (intent-to-treat population) received either amoxicillin/clavulanate 2000/125 mg (n = 374) or amoxicillin/clavulanate 875/125 mg (n = 192).

Results: Among the patients who did not deviate from the protocol (clinical per-protocol population), clinical success at day 21-28 post-therapy (test of cure; primary efficacy endpoint) was 92.4% (266/288) for amoxicillin/clavulanate 2000/125 mg and 91.2% (135/148) for amoxicillin/clavulanate 875/125 mg (treatment difference, 1.1; 95% confidence interval, -4.4, 6.6). Bacteriological success at test of cure in the bacteriology per-protocol population was 90.8% (79/87) with amoxicillin/clavulanate 2000/125 mg and 86.0% (43/50) with amoxicillin/clavulanate 875/125 mg (treatment difference 4.8; 95% confidence interval, -6.6, 16.2). At test of cure, amoxicillin/clavulanate 2000/125 mg was clinically and bacteriologically effective against 7/7 penicillin-resistant Streptococcus pneumoniae (MIC ≥2 mg/L) isolates (including three amoxicillin non-susceptible strains) and amoxicillin/clavulanate 875/125 mg against 5/5 isolates (including one amoxicillin non-susceptible strain).

Conclusions: Both treatment regimens were well tolerated. Amoxicillin/clavulanate 2000/125 mg was at least as effective clinically and as safe as amoxicillin/clavulanate 875/125 mg in the treatment of community-acquired pneumonia in adults in a country with a high prevalence of penicillin-resistant S. pneumoniae and has a more convenient twice daily posology.

Keywords: anti-infective development; antimicrobial therapy; {beta}-lactams.
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