Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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For treatment studies of an infectious disease, such as pneumonia, microbiologic eradication is the logical primary end point. Several problems for pneumonia in general and several more specific to VAP preclude the use of microbiologic eradication as a primary end point. These problems include no positive culture result at baseline, difficulty distinguishing colonization from infection on baseline cultures, no specimen available for testing when determining cure, and induction of colonization by antibiotic treatment. ⋯ Although promising, especially for open-label studies focused on multidrug-resistant pathogens, further research is needed before serial quantitative cultures can be used to define microbiologic failure. Of the biomarkers, procalcitonin level may be a valuable adjunct to clinical evaluation but cannot be a primary end point alone. A decreasing or low procalcitonin level after initiation of antibiotic treatment correlates well with bacterial eradication.
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There is an increasing focus on having quality systems in place during the planning stages of clinical trials. Such systems require the development and implementation of standards for each step. Although this is not imposing something totally new on clinical research, a systematic approach will produce a more reliable and useful end product--high-quality data obtained without compromising the protection of human subjects' rights and welfare. A suggested quality system with standards for each step is addressed in this article.