Aspects of clinical trials with XXXX worldwide.

@entity1 @entity17158 @entity7660 @entity1398 @entity581 @entity5505
Overall results from worldwide clinical studies of @entity5505 in open and comparative trials conducted over a four-year period in North America, Europe, and elsewhere are presented. Data from 3,570 @entity1 treated with @entity5505 in open studies and from 1,340 @entity1 receiving @entity5505 and 1,180 @entity1 receiving other antibiotics in comparative studies are discussed. The comparative antibiotics consisted of @entity581 alone in 14.2 percent of @entity1 , @entity581 combined with one or two @entity7660 in 43 percent, @entity7660 alone in 34 percent, and other antibiotic combinations in 8.8 percent. In comparative studies, bacterial clearance rates were 80.6 percent for @entity5505 and 72.5 percent for other antibiotics. Clinically, 92.6 percent of the infected sites in @entity5505 -treated @entity1 in open studies were cured or improved, and 91.1 percent were cured or improved in comparative studies; 84.8 percent of the infected sites were cured or improved in @entity1 treated with other antibiotics. Data indicate that @entity5505 monotherapy is as effective as combination antibiotic therapy in the empiric treatment of febrile non- @entity1398 @entity1 . The role of @entity5505 monotherapy in the treatment of febrile @entity1398 @entity1 is not yet firmly established. @entity17158 were reported in 2.6 percent of the @entity1 treated with @entity5505 alone in open trials, in 4.2 percent of the @entity1 treated with @entity5505 alone in comparative trials, and in 8.5 percent of the @entity1 treated with other antibiotics. During treatment, the sensitivity of bacteria to @entity5505 decreased in 2.5 percent of the pathogens isolated. Adverse events occurred in 10.2 percent of @entity1 treated with @entity5505 in open studies, in 8.4 percent of those treated with @entity5505 in comparative studies, and in 8.8 percent of those treated with other antibiotics. The adverse events in both @entity5505 - and control-treated @entity1 were thought by the investigators to be drug-related in about 40 percent of cases, not drug-related in 20 percent of cases, and of unknown etiology in the remaining cases.
