Increasing the Quality and Efficiency of Clinical Trials

Project: Research project

Project Details


The primary study objectives are to 1) estimate the rates of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) developing in intensive care unit (ICU) patients considered high risk for pneumonia, as defined by treatment with one or more of the following respiratory modalities for at least 12 hours, either currently or within the prior 7 days: ---Invasive mechanical ventilation ---Noninvasive ventilation (bilevel positive airway pressure BiPAP] or continuous positive airway pressure [CPAP] for any indication other than obstructive sleep apnea) ---High-flow, supplemental oxygen therapy via nasal cannula. Only include systems using an air/oxygen blender capable of delivering a precise fraction of inspired oxygen [FiO2] level, not just a flow in liters per minute (LPM) ---High flow supplemental oxygen therapy delivering at least 50% FiO2 via aerosol facemask or tracheostomy collar (mask). Only include systems using an air/oxygen blender capable of delivering a precise FiO2 level, not just a flow in LPM. ---Supplemental oxygen therapy delivered via either partial or non-rebreather face mask. 2) estimate the proportion of patients diagnosed with HABP/VABP who would be eligible for enrollment in a clinical trial of antibacterial therapy for HABP/VABP per U.S. Food and Drug Administration (FDA) draft guidance document criteria.
Effective start/end date1/29/168/31/19


  • Duke University (5R18FD005292-02 ADDENDUM)
  • Food and Drug Administration (5R18FD005292-02 ADDENDUM)


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