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% 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.
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Authors | Javier Garau, Monique Twynholm, Elena Garcia-Mendez, Bartolome Siquier, Antonio Rivero, 557 Clinical Study Group |
Journal | The Journal of antimicrobial chemotherapy
(J Antimicrob Chemother)
Vol. 52
Issue 5
Pg. 826-36
(Nov 2003)
ISSN: 0305-7453 [Print] England |
PMID | 14563899
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Amoxicillin-Potassium Clavulanate Combination
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Amoxicillin-Potassium Clavulanate Combination
(administration & dosage, therapeutic use)
- Community-Acquired Infections
(drug therapy, microbiology)
- Double-Blind Method
- Drug Therapy, Combination
(administration & dosage, therapeutic use)
- Female
- Humans
- Male
- Middle Aged
- Pneumonia, Pneumococcal
(drug therapy, microbiology)
- Streptococcus pneumoniae
(drug effects)
- Treatment Outcome
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