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These data support the ongoing development of a PRO measure for nv HABP , similar to what is being done for CABP . Study strengths include the diverse databases explored, their recent vintages, and the novel hypotheses explored. Limitations of these analyses include their retrospective nature and the interrogation of selected study datasets. Pneumonia symptom data may not have been elicited as actively as with administration of a PRO instrument. Additionally, data analysis was performed within the constraints of the sponsors original study design and data capture, including the inability for comprehensive baseline pathogen identification or specific bacterial resistance phenotype. These considerations do not impact conclusions about the utility of an ACM+ endpoint or the development of an nv HABP PRO. In summary, these analyses produced useful insights into future HABP/VABP study design options that could provide flexibility to sponsors, improve study feasibility, and maintain scientific rigor. Presented in part: 28th European Congress of Clinical Microbiology and Infectious Diseases, Madrid, Spain, 2124 April 2018 and American Society for Microbiology Microbe, Atlanta GA, 47 June 2018. In addition, details of the work were submitted to the US Food and Drug Administration docket: Considerations for Clinical Trial Design for the Study of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacteria Pneumonia. Foundation for the National Institutes of Health Biomarkers Consortium HABP/VABP Project Team for HABP/VABP draft guidance, 13 June 2017, submission to docket number FDA 2010 D 0589. Acknowledgments.

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Md. Enamul Hoque, Ph. D. Xingchun WangNEW PERSPECTIVES IN ELTSelected Papers from the National Seminar on New Perspectives in ELT Conducted by the Department of EnglishTheni Kammavar Sangam College of Technology, Theni 625534Tamilnadu, India . Editors: D. Nagarathinam, Ph.

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