Streamling HABP/VABP Trials

>> Project Summary

 

AB Drug Development

Streamling Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Clinical Trials

CTTI Project Category: AB Drug Development

Project Status: Current

 

What is the issue?

As a society, we urgently need new types of antibiotic drugs because many bacteria have developed resistance to one or more existing antibiotics. At the same time, fewer drug companies are working on bringing new antibiotics to market. That’s because antibiotic trials are complicated and expensive, and there is little economic incentive to develop drugs that are usually taken for short periods of time rather than long term. In particular, drug trials testing new antibiotics designed to treat bacterial pneumonia acquired as a result of a hospital stay or in association with a ventilator are notoriously complicated, lengthy, and expensive.

 

What is the goal of this project?

The goal of this project is to identify barriers and seek solutions for the successful conduct of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) trials.

 

What are the objectives of this project?

  • Identify barriers and seek solutions for the successful conduct of HABP/VABP studies (Workstream 1 - Protocol Elements)
  • Simplify and reduce the amount of (safety) data collected in the HABP/VABP studies (Workstream 2 - Data Collection)
  • Build a pilot network of sites to conduct HABP/VABP studies (Workstream 3 - ID Site Networks)

 

What will we produce?

  • Recommendations on alternate study design elements to overcome barriers in HABP/VABP studies (Workstream 1 - Protocol Elements)
  • Recommendations on critical data to be collected to simplify data collection (Workstream 2 - Data Collection)
  • A pilot network of 30-50 sites to conduct HABP/VABP trials (Workstream 3 - ID Site Networks)

 

What is the anticipated impact?

  • A trial using the recommendations will show that an innovative approach will work, leading to availability of more antibiotics (Workstream 1 - Protocol Elements)
  • Accelerating study conduct and reducing the cost associated with excess data collection (Workstream 2 - Data Collection)
  • Streamlining and accelerating the conduct of HABP/VABP studies (Workstream 3 - ID Site Networks)