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Amoxicillin-clavulanate at 2,000\/125 mg was designed to extend the therapeutic levels of amoxicillin in serum over the 12-h dosing interval, compared with conventional formulations, to eradicate bacterial strains for which amoxicillin MICs were \u22644 \u03bcg\/ml while retaining efficacy against \u03b2-lactamase-producing pathogens. A total of 893 patients were randomized and received study medication (amoxicillin-clavulanate at 2,000\/125 mg for 443 patients and 875\/125 mg for 450 patients). Overall, 141 patients receiving amoxicillin-clavulanate at 2,000\/125 mg and 135 receiving the comparator formulation had at least one pathogen identified at screening. Amoxicillin-clavulanate at 2,000\/125 mg was as effective clinically in the per-protocol (PP) population at the test of cure (days 14 to 21, primary efficacy endpoint) as amoxicillin-clavulanate at 875\/125 mg (clinical success rates of 93.0 and 91.2%, respectively; treatment difference, 1.8; 95% confidence interval [CI], \u22122.2, 5.7). Bacteriological success in the bacteriology PP population was high for both formulations (amoxicillin-clavulanate at 2,000\/125 mg, 76.7%; amoxicillin-clavulanate at 875\/125 mg, 73.0%; treatment difference, 3.8; 95% CI, \u22127.5, 15.0). Both therapies were well tolerated, with a similar incidence of adverse events. Fewer than 5% of patients in each group withdrew from the study due to adverse events. The shorter, 5-day course of amoxicillin-clavulanate at 2,000\/125 mg was shown to be as effective clinically as a longer, 7-day course of amoxicillin-clavulanate at 875\/125 mg, with high bacteriological efficacy and no difference in tolerability.<\/jats:p>","DOI":"10.1128\/aac.49.1.153-160.2005","type":"journal-article","created":{"date-parts":[[2004,12,23]],"date-time":"2004-12-23T09:36:20Z","timestamp":1103794580000},"page":"153-160","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":33,"title":["Efficacy and Safety of Pharmacokinetically Enhanced Amoxicillin-Clavulanate at 2,000\/125 Milligrams Twice Daily for 5 Days versus Amoxicillin-Clavulanate at 875\/125 Milligrams Twice Daily for 7 Days in the Treatment of Acute Exacerbations of Chronic Bronchitis"],"prefix":"10.1128","volume":"49","author":[{"given":"Sanjay","family":"Sethi","sequence":"first","affiliation":[{"name":"University of Buffalo, Buffalo, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Breton","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Collegeville, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Wynne","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Collegeville, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_1_2_2","first-page":"13A","volume":"28","year":"2000","unstructured":"Adam, D. 2000. 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