Treating acute bacterial exacerbations of chronic bronchitis in patients unresponsive to previous therapy: sparfloxacin versus clarithromycin
Abstract
The optimal antibiotic therapy for patients with acute bacterial exacerbations of chronic bronchitis (ABECB) who have failed to respond to previous oral antimicrobial therapy is not known; however, newer macrolide and fluoroquinolone antibiotics may be appropriate. This multicenter, randomized, double-masked, double-dummy study was undertaken to compare the efficacy and tolerability of sparfloxacin with those of clarithromycin in the treatment of ABECB. In 43 centers in the United States, 298 patients (52% male; age range, 19 to 92 years) were randomly allocated to receive a 400-mg loading dose of sparfloxacin, followed by 200 mg once daily, or clarithromycin 500 mg twice daily, for a total of 10 days. Signs and symptoms of ABECB were assessed at each of 4 visits, including a follow-up visit approximately 1 month after the completion of therapy. Efficacy was determined on the basis of the clinical and bacteriologic response rates in the clinically assessable population. Tolerability was assessed on the basis of patient reports, clinical evaluations, and laboratory tests. Of the 266 clinically assessable patients, 109 (85.2%) of 128 patients receiving sparfloxacin and 115 (83.3%) of 138 patients receiving clarithromycin had a clinically successful outcome (cure or improvement). The bacteriologic success rate (eradication of pathogen) was 88.9% (64 of 72 isolates) in the sparfloxacin group and 84.7% (83 of 98 isolates) in the clarithromycin group. Adverse events possibly or…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 298 participants or records.
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