title: Considerations in undertaking a clinical development program for hospital-acquired bacterial pneumonia and/or ventilator-associated bacterial pneumonia.
abstract: Achieving marketing authorization for an antimicrobial for the treatment of hospital-acquired bacterial pneumonia (HABP) and/or ventilator-associated bacterial pneumonia (VABP) is challenging because each clinical trial and each clinical development program must address the requirements of multiple, worldwide audiences, including clinicians and regulators. Complex, lengthy and particularly costly trials constitute additional hurdles. Specific impediments to successful trials, although legion (eg, regional variability in clinical practice or regulatory guidance), can be overcome. The core components of a HABP and/or VABP development program include robust nonclinical and clinical enabling data for the candidate antibiotic (eg, delineation of in vitro potency against relevant pathogens and pulmonary penetration and efficacy in animals) and pharmacokinetic-pharmacodynamic modeling. Sponsors must anticipate potential confounding factors, such as pharmacokinetic variability in the population enrolled. With use of appropriate enabling data, various types and combinations of phase 3 pivotal trials could suffice for regulatory approval of the HABP and/or VABP indications.
authors.affiliation: Talbot Advisors, St Davids, Pennsylvania 19087, USA. talbot@aya.yale.edu
authors.forename: George H
authors.initials: GH
authors.lastname: Talbot
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D003428:Cross Infection / Q000188:drug therapy*; D017277:Drug Approval; D055808:Drug Discovery; D006761:Hospitals; D006801:Humans; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D053717:Pneumonia, Ventilator-Associated / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents