Aerosolized and Intravenous Colistin in Healthy Adults
Status:
Terminated
Trial end date:
2017-05-04
Target enrollment:
Participant gender:
Summary
Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is
administered intramuscularly, intravenously (IV) or via inhalation. In the case of pneumonia,
aerosolized route of administration is favorable as it presumably delivers a high
concentration of drug directly to the infection site. Colistimethate sodium is an FDA
approved drug, however, its aerosolized use represents a new method of administration not
currently FDA-approved in the United States. In this proposal, the inactive prodrug
colistimethate sodium has been selected to use for aerosolization as it is better tolerated
than colistin sulphate. It is a randomized, open-labeled Phase 1 trial of aerosolized and/or
IV formulations of colistin as multiple doses over seven days. The primary objective of this
trial is to evaluate the safety and tolerability of multiple doses of aerosolized and
intravenous colistimethate sodium separately or in combination in healthy adult subjects.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)