JAC Advance Access published online on October 16, 2003
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkg458
© 2003 by The British Society for Antimicrobial Chemotherapy
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Original article
1 Department of Medicine,
Hospital Mutua de Terrassa, Barcelona;
* Corresponding author. E-mail: jagarau{at}terra.es.
Received 10 June 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
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
2 GlaxoSmithKline,
Harlow, UK
3 GlaxoSmithKline, Madrid;
4 Hospital Son Dureta, Palma de Mallorca;
5 Hospital Reina Sofía,
Cordoba, Spain;
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  W S Lim, S V Baudouin, R C George, A T Hill, C Jamieson, I Le Jeune, J T Macfarlane, R C Read, H J Roberts, M L Levy, et al. BTS guidelines for the management of community acquired pneumonia in adults: update 2009 Thorax, October 1, 2009; 64(Suppl_3): iii1 - iii55. [Full Text] [PDF]
|
|
|
|
 |
|
 M. E. Falagas, I. I. Siempos, I. A. Bliziotis, and G. Z. Panos Impact of Initial Discordant Treatment With {beta}-Lactam Antibiotics on Clinical Outcomes in Adults With Pneumococcal Pneumonia: A Systematic Review Mayo Clin. Proc., December 1, 2006; 81(12): 1567 - 1574. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 B. Siquier, J. Sanchez-Alvarez, E. Garcia-Mendez, M. Sabria, J. Santos, R. Pallares, M. Twynholm, R. Dal-Re, and on behalf of the 620 Clinical Study Group 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 J. Antimicrob. Chemother., March 1, 2006; 57(3): 536 - 545. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. Gracia, C. Martinez-Marin, L. Huelves, M. J. Gimenez, L. Aguilar, A. Carcas, C. Ponte, and F. Soriano Pulmonary Damage and Bacterial Load in Assessment of the Efficacy of Simulated Human Treatment-Like Amoxicillin (2,000 Milligrams) Therapy of Experimental Pneumococcal Pneumonia Caused by Strains for Which Amoxicillin MICs Differ Antimicrob. Agents Chemother., March 1, 2005; 49(3): 996 - 1001. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Sevillano, A. Calvo, M.-J. Gimenez, L. Alou, L. Aguilar, E. Valero, A. Carcas, and J. Prieto Bactericidal activity of amoxicillin against non-susceptible Streptococcus pneumoniae in an in vitro pharmacodynamic model simulating the concentrations obtained with the 2000/125 mg sustained-release co-amoxiclav formulation J. Antimicrob. Chemother., December 1, 2004; 54(6): 1148 - 1151. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
I. Odenholt, O. Cars, and E. Lowdin Pharmacodynamic studies of amoxicillin against Streptococcus pneumoniae: comparison of a new pharmacokinetically enhanced formulation (2000 mg twice daily) with standard dosage regimens J. Antimicrob. Chemother., December 1, 2004; 54(6): 1062 - 1066. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Kosowska, M. R. Jacobs, S. Bajaksouzian, L. Koeth, and P. C. Appelbaum Alterations of Penicillin-Binding Proteins 1A, 2X, and 2B in Streptococcus pneumoniae Isolates for Which Amoxicillin MICs Are Higher than Penicillin MICs Antimicrob. Agents Chemother., October 1, 2004; 48(10): 4020 - 4022. [Abstract] [Full Text] [PDF]
|
|