Titre du document / Document title

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

Auteur(s) / Author(s)

620 Clinical Study Group
SIQUIER B. ⁽¹⁾ ; SANCHEZ-ALVAREZ J. ⁽²⁾ ; GARCIA-MENDEZ E. ⁽³⁾ ; SABRIA M. ⁽⁴⁾ ; SANTOS J. ⁽⁵⁾ ; PALLARES R. ⁽⁶⁾ ; TWYNHOLM M. ⁽⁷⁾ ; DAL-RE R. ⁽³⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

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

Résumé / 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.

Revue / Journal Title

Journal of antimicrobial chemotherapy   ISSN 0305-7453   CODEN JACHDX 

Source / Source

2006, vol. 57, n^o3, pp. 536-545 [10 page(s) (article)] (32 ref.)

Langue / Language

Anglais

Editeur / Publisher

Oxford University Press, Oxford, ROYAUME-UNI  (1975) (Revue)

Mots-clés anglais / English Keywords

Lung disease ; Respiratory disease ; Enzyme inhibitor ; Enzyme ; Hydrolases ; β-Lactamase ; Penicillin derivatives ; Infection ; Bacteriosis ; Streptococcal infection ; Bacteria ; Micrococcales ; Streptococcaceae ; Human ; Antibiotic ; Antibacterial agent ; β-Lactams ; Antimicrobial agent ; Antiinfectious ; Pneumococcal infection ; Streptococcus pneumoniae ; Epidemiology ; Prevalence ; Countries ; Pneumonia ; Community acquired infection ; Adult ; Treatment ; Clavulanic acid ; Amoxicillin ; Toxicity ; Efficiency ;

Mots-clés français / French Keywords

Poumon pathologie ; Appareil respiratoire pathologie ; Inhibiteur enzyme ; Enzyme ; Hydrolases ; β-Lactamase ; Pénicilline dérivé ; Infection ; Bactériose ; Streptococcie ; Bactérie ; Micrococcales ; Streptococcaceae ; Homme ; Souche résistante pénicilline ; Antibiotique ; Antibactérien ; β-Lactamines ; Antimicrobien ; Antiinfectieux ; Pneumococcie ; Streptococcus pneumoniae ; Epidémiologie ; Prévalence ; Pays ; Pneumonie ; Infection communautaire ; Adulte ; Traitement ; Acide clavulanique ; Amoxicilline ; Toxicité ; Efficacité ;

Mots-clés espagnols / Spanish Keywords

Pulmón patología ; Aparato respiratorio patología ; Inhibidor enzima ; Enzima ; Hydrolases ; β-Lactamase ; Penicilinas ; Infección ; Bacteriosis ; Estreptococia ; Bacteria ; Micrococcales ; Streptococcaceae ; Hombre ; Antibiótico ; Antibacteriano ; β-Lactams ; Antimicrobiano ; Antiinfeccioso ; Neumococia ; Streptococcus pneumoniae ; Epidemiología ; Prevalencia ; País ; Neumonía ; Infección comunitaria ; Adulto ; Tratamiento ; Acido clavulánico ; Amoxicilina ; Toxicidad ; Eficacia ;

Mots-clés d'auteur / Author Keywords

anti-infective development ; antimicrobial therapy ; β-lactams ;

Localisation / Location

INIST-CNRS, Cote INIST : 17084, 35400013249025.0190