FEBRUARY 24, 2015

CTTI Project: HABP/VABP Studies

Meeting Goal

To determine the study design for the CTTI Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) pilot study. The study will test the principles and recommendations identified in the CTTI Program on Antibacterial Drug Development (ABDD).

Meeting Location:

Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Rd, Bethesda, Maryland 20852

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentations:

• Introduction by Pamela Tenaerts, MD, MBA, CTTI
• Project Overview by Rosemary Tiernan, MD, MPH, Office of Medical Policy/CDER/FDA
• CTTI HABP/VABP Pilot Study Preliminary Planning by Sara Bristol Calvert, PharmD, CTTI
• Calculating the Direct and Indirect Costs of a Phase III HABP/VABP Clinical Study by Stella Stergiopoulos, Tufts CSDD
• CTTI HABP/VABP Pilot: Proposed Study Designs by Vance Fowler, MD, MHS, Duke University Medical Center

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.