This study is a multi-center randomized, double-blind placebo-controlled multiple dose, dose-escalation cohort protocol to evaluate the safety and preliminary biological efficacy of a novel antibiotic, a synthetic protegrin analogue, IB-367, delivered to the lower respiratory tract of patients with cystic fibrosis by jet nebulization. Protegrins are a class of endogenous (naturally occurring) antibiotics found in several mammalian species and exhibit wide-ranging potent bacterial killing effects. They are salt-insensitive (unlike defensins) making them attractive candidates for novel antibiotic therapeutic agents in cystic fibrosis, where some evidence for high salt concentrations in airway surface fluids have been reported. Evidence of antimicrobial efficacy in this protocol has been sought by quantitative microbiology of cultures obtained from expectorated sputum (counting bacteria). Safety measures have included multiple serial pulmonary function tests.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000070-38
Application #
6408824
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
38
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Stanford University
Department
Type
DUNS #
800771545
City
Stanford
State
CA
Country
United States
Zip Code
94305
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