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CLINICAL STUDIES Study One: In a controlled clinical study of acute otitis media performed in the United States where significant rates of -lactamase-producing organisms were found, cefprozil was com-pared to an oral antimicrobial agent that contained a specific -lactamase inhibitor. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10-16 days post-therapy follow-up, the following presumptive bacterial eradication / clinical cure outcomes (i. e. clinical success) and safety results were obtained:
U. S. Acute Otitis Media Study Text Continues Below
Cefprozil vs -lactamase inhibitor-containing control drug
EFFICACY:
Pathogen % of Cases with Pathogen Outcome (n = 155) S. pneumoniae 48.4% cefprozil success rate 5% better than control
H. influenzae 35.5% cefprozil success rate 17% less than control
M. catarrhalis 13.5% cefprozil success rate 12% less than control
S. pyogenes 2.6% cefprozil equivalent to control
Overall 100.0% cefprozil success rate 5% less than control SAFETY: The incidences of adverse events, primarily diarrhea and rash*, were clinically and statistically significantly higher in the control arm versus the cefprozil arm.
Age Group Cefprozil Control 6 months-2 years 21% 41%
3-12 years 10% 19% *The majority of these involved the diaper area in young children. Study Two: In a controlled clinical study of acute otitis media performed in Europe, cefprozil was compared to an oral antimicrobial agent that contained a specific -lactamase inhibitor. As expected in a European population, this study population had a lower incidence of -lactamase-producing organisms than usually seen in U. S. trials. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10-16 days post-therapy follow-up, the following presumptive bacterial eradication / clinical cure outcomes (i. e. clinical success) were obtained: Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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