Increasing the Quality and Efficiency of Clinical trials

Project: Research project

Project Details


The Clinical Trial Transformation Initiative (CTTI) is a collaborative organization that seeks to improve the quality and efficiency of clinical trials. The CTTI Streamlining HABP/VABP Trials Project seeks to better understand and address the challenges of conducting HABP/VABP clinical trials. A HABP/VABP pilot study (Early Enrollment Pilot Study), incorporating many of the recommendations from the CTTI Streamlining HABP/VABP Trials Project, is planned. The primary objective is to conduct a study that will lead to improved HABP/VABP clinical trial feasibility. The proposed design of the future pilot study is a randomized trial comparing early enrollment and traditional enrollment strategies. The early enrollment strategy (treatment arm) will include approaching AND consenting patients at high risk for developing pneumonia, many before pneumonia symptoms develop. The rationale of this early enrollment strategy is to identify and enroll high-risk patients before they have received more than 24 hours of effective antibacterial therapy, a common challenge to enrollment in HABP/VABP trials. Prior to conducting the early enrollment study, an observational study will be conducted to better define the population at highest risk for developing HABP/VABP. The Risk Factors for HABP/VABP Study is prospective, multi-center, observational study of adult patients (≥18 years old) admitted to ICUs. Baseline data will be collected on a subset of the ICU patients treated with select respiratory modalities that are considered high risk for the development of HABP/VABP or on patients who are not high-risk but are receiving antibiotic treatment for suspected pneumonia. Additional data is collected if the patient is treated with antibiotics for either a lower respiratory tract infection (LRTI) or undifferentiated sepsis. All subjects treated with antibiotics for either indication will subsequently be screened for the development of pneumonia, as defined by the FDA draft guidance document for drug development in HABP/VABP. Subjects who meet the FDA draft guidance definition of pneumonia will have vitals and physiologic data collected and will be followed for 4 days after pneumonia is diagnosed to capture the results of any microbiologic testing and changes to antibiotic therapy. The primary endpoint is the proportion of subjects who develop HABP/VABP. This data will be used to finalize the Early Enrollment Pilot Study. Enrollment for the pilot study will being in after the pilot study is completed.
Effective start/end date2/1/168/31/18


  • Duke University (203-7585//5R18FD005292-04)
  • Food and Drug Administration (203-7585//5R18FD005292-04)


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