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Titre du document / Document title

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

Auteur(s) / Author(s)

557 Clinical Study Group
GARAU Javier (1) ; TWYNHOLM Monique (2) ; GARCIA-MENDEZ Elena (3) ; SIQUIER Bartolome (4) ; RIVERO Antonio (5) ;

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

(1) Department of Medicine, Hospital Mutua de Terrassa, Barcelona, ESPAGNE
(2) GlaxoSmithKline, Madrid, ESPAGNE
(3) Hospital Son Dureta, Palma de Mallorca, ESPAGNE
(4) Hospital Reina Sofía, Cordoba, ESPAGNE
(5) GlaxoSmithKline, Harlow, ROYAUME-UNI

Résumé / Abstract

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% Cl: 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% Cl: 15.8, 31.2). Penicillin-resistant S. pneumoniae (PRSP) were isolated in three patients (including two with bacteraemia) in the co-amoxiclav2000/125 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.

Revue / Journal Title

Journal of antimicrobial chemotherapy    ISSN  0305-7453   CODEN JACHDX 

Source / Source

2003, vol. 52, no5, pp. 826-836 [11 page(s) (article)] (28 ref.)

Langue / Language

Anglais

Editeur / Publisher

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

Mots-clés anglais / English Keywords

Lung disease

;

Respiratory disease

;

Enzyme

;

Hydrolases

;

β-Lactamase

;

Enzyme inhibitor

;

β-Lactams

;

Penicillin derivatives

;

Antibacterial agent

;

Antibiotic

;

Bacteria

;

Micrococcales

;

Streptococcaceae

;

Oral administration

;

Administration schedule

;

Immediate release form

;

Controlled release form

;

Dosage form

;

Drug combination

;

Treatment

;

Human

;

Chemotherapy

;

Community acquired infection

;

Streptococcus pneumoniae

;

Pneumonia

;

Clavulanic acid

;

Amoxicillin

;

Mots-clés français / French Keywords

Poumon pathologie

;

Appareil respiratoire pathologie

;

Enzyme

;

Hydrolases

;

β-Lactamase

;

Inhibiteur enzyme

;

β-Lactamines

;

Pénicilline dérivé

;

Antibactérien

;

Antibiotique

;

Bactérie

;

Micrococcales

;

Streptococcaceae

;

Voie orale

;

Rythme administration

;

Forme libération immédiate

;

Forme libération contrôlée

;

Forme pharmaceutique

;

Association médicamenteuse

;

Traitement

;

Homme

;

Chimiothérapie

;

Infection communautaire

;

Streptococcus pneumoniae

;

Pneumonie

;

Acide clavulanique

;

Amoxicilline

;

Mots-clés espagnols / Spanish Keywords

Pulmón patología

;

Aparato respiratorio patología

;

Enzima

;

Hydrolases

;

β-Lactamase

;

Inhibidor enzima

;

β-Lactams

;

Penicilinas

;

Antibacteriano

;

Antibiótico

;

Bacteria

;

Micrococcales

;

Streptococcaceae

;

Vía oral

;

Ritmo administración

;

Forma liberación inmediata

;

Forma liberación controlada

;

Forma farmacéutica

;

Asociación medicamentosa

;

Tratamiento

;

Hombre

;

Quimioterapia

;

Infección comunitaria

;

Streptococcus pneumoniae

;

Neumonía

;

Acido clavulánico

;

Amoxicilina

;

Localisation / Location

INIST-CNRS, Cote INIST : 17084, 35400011488435.0140

Nº notice refdoc (ud4) : 15261245



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