Journal Article

Considerations in Undertaking a Clinical Development Program for Hospital-Acquired Bacterial Pneumonia and/or Ventilator-Associated Bacterial Pneumonia

George H. Talbot

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue Supplement_1, pages S144-S149
Published in print August 2010 | ISSN: 1058-4838
Published online August 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/653064
Considerations in Undertaking a Clinical Development Program for Hospital-Acquired Bacterial Pneumonia and/or Ventilator-Associated Bacterial Pneumonia

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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 additionalhurdles. 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 pharmacokineticpharmacodynamic 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.

Journal Article.  3256 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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