An objective approach for Burkholderia pseudomallei strain selection as challenge material for medical countermeasures efficacy testing.

ABSTRACT: Burkholderia pseudomallei is the causative agent of melioidosis, a rare disease of biodefense concern with high mortality and extreme difficulty in treatment. No human vaccines are available that protect against B. pseudomallei infection, and with the current limitations of antibiotic treatment, the development of new preventative and therapeutic interventions is crucial. Although clinical trials could be used to test the efficacy of new medical countermeasures (MCMs), the high mortality rates associated with melioidosis raises significant ethical issues concerning treating individuals with new compounds with unknown efficacies. The US Food and Drug Administration (FDA) has formulated a set of guidelines for the licensure of new MCMs to treat diseases in which it would be unethical to test

SUBMITTER: Van Zandt KE 

PROVIDER: S-EPMC3458228 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature