Infectious Diseases Research Lab at Mayo Clinical Endocarditis Registry
Strength: first study to evaluate susceptibility patterns temporally for endocardial infections Weakness:
Pcn mic <0.03, ctx 0.25
Pcn mic <0.03, ctx 0.25
Phase III studies are designed to compare one or more treatments. A new drug or drug combination may be tested against one of proven efficacy. Phase III studies often have multiple endpoints. Overall and disease-free survival are nearly always endpoints; differences in response rates, toxicity, patterns of recurrence, and quality of life might also be endpoints. At the conclusion of a properly designed and conducted phase III study, the new drug or drug combination will be found to be inferior, equivalent, or superior to the standard treatment with respect to the major endpoints. The degree of difference will be known and statistical significance will be estimated
No relapses occurred. Clinical cure was observed in 25(96.2%) of 26 monotherapy and 24 (96%) 25 combination therapy recipients. Total of 5 monotherapy pts received cardiac surgery a mean of 37.1 days after antimicrobial therapy. Total of 9 combination therapy recipients required cardiac surgery at mean 22 2 combination therapy pts had a rise in their serum creatinine Mean duration of hospitalization was 8 days for montherapy and 14.5 days for combination therapy.