Criteria & Principles
See attachment for more guidance on how to procure agents to treat MDRO and details on susceptibility testing of these agents.
See Adult Rapid Diagnostics page or Pediatric Rapid Diagnostics page for empiric antibiotic choices for bloodstream infections when genetic markers (e.g. KPC gene) were detected.
References
Treatment of individual patients with investigational new drugs (INDs)
Duke University Hospital is sponsoring support for Duke Health providers to obtain access to non-FDA approved, investigational drugs for treatment of individual patients under the FDA’s expanded access program. Expanded access is the use of an investigational product outside of a clinical trial to diagnose, monitor or treat patients with serious or immediately life-threatening diseases or conditions for which there are no acceptable alternative therapies.
This support for individual patient requests will assist providers with institutional and regulatory approvals, including Duke's hospital pharmacy and therapeutics committee approval, drug company and FDA approval, Investigational Drug Services (IDS/ICS), as well as with contracts and placing the order in Duke Maestro Care.
A trained regulatory scientist from ORAQ (Duke Office of Regulatory Affairs and Quality) will assist with FDA and drug company communications, while a trained core of research coordinators will submit the application to the Institutional Review Board (IRB). This service is provided at no cost to the provider.
Learn more about expanded access or request support https://medschool.duke.edu/research/research-support-offices/office-regulatory-affairs-and-quality/expanded-access