The efficacy and safety of oral pharmacokinetically enhanced amoxycillin–clavulanate 2000/125 mg, twice daily, versus oral amoxycillin–clavulanate 1000/125 mg, three times daily, for the t

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• 作者：Petitpretz ; Patrick ; Chidiac ; Christian ; Soriano ; Francisco ; Garau ; Javier ; Stevenson ; Katharine ; et. al.
• 关键词：Amoxycillin&ndash ; clavulanate ; Pharmacokinetically enhanced ; Penicillin-resistant Streptococcus pneumoniae
• 刊名：International Journal of Antimicrobial Agents
• 出版年：2002
• 出版时间：August, 2002
• 年：2002
• 卷：20
• 期：2
• 页码：119-129
• 全文大小：150 K

文摘

This double-blind, double-dummy, parallel-group study was designed to show that a pharmacokinetically enhanced formulation of oral amoxycillin–clavulanate (16:1, 2000/125 mg), twice daily, is at least as effective clinically and microbiologically as oral amoxycillin–clavulanate 1000/125 mg, three times daily, in the 10 day treatment of community-acquired pneumonia (CAP) in adults. The pharmacokinetically enhanced formulation is designed to provide higher serum concentrations of amoxycillin for a longer period than standard dosing to achieve coverage of Streptococcus pneumoniae isolates with amoxycillin–clavulanic acid minimum inhibitory concentrations (MICs) up to and including 4 mg/l. A total of 344 patients with CAP from 77 centres received amoxycillin–clavulanate 2000/125 mg twice daily for 10 days (169 patients) or amoxycillin–clavulanate 1000/125 mg three times daily for 10 days (175 patients). The most common pathogen isolated was S. pneumoniae (52.3 % of patients, amoxycillin–clavulanate 2000/125 mg group; 46.8 % of patients, amoxycillin–clavulanate 1000/125 mg group). In the clinical per-protocol (PP) population at test of cure (days 18–39), the clinical success rate in the amoxycillin–clavulanate 2000/125 mg group was at least as good as in the amoxycillin–clavulanate 1000/125 mg group (91.5 and 93.0 % , respectively; 95 % CI, −8.3, 5.4). The radiological and bacteriological success rates at test of cure for the PP populations were 92.4 and 90.6 % in the amoxycillin–clavulanate 2000/125 mg group and 93.9 and 84.4 % in the amoxycillin–clavulanate 1000/125 mg group, respectively. The clinical, bacteriological and radiological success rates at the end of therapy (days 11–17) for the PP populations were all over 85 % . Both regimens were well tolerated, with no differences in adverse events between the groups. Amoxycillin–clavulanate 2000/125 mg, twice daily, is well tolerated and at least as effective clinically as amoxycillin–clavulanate 1000/125 mg, three times daily, in patients with CAP and may also be appropriate for the treatment of infections due to S. pneumoniae strains with high-level penicillin resistance.