40
Participants
Start Date
September 12, 2022
Primary Completion Date
August 31, 2025
Study Completion Date
November 30, 2025
Intravenous infusion of N-acetylcysteine
If randomized to Control, the participant will receive only N-acetylcysteine. The dose will be determined by the site investigator. Typical continued infusion rate is 6.25 mg/kg/hr. The control drug (D5W) will be administered using the same schedule as fomepizole.
Intravenous infusion of Fomepizole (4-MP)
If randomized to fomepizole, the proposed infusion schedule for fomepizole closely mirrors the dosing outlined in the medication's package insert. Specifically, the Antizol (fomepizole) doses (bags) #1-5 allocated for the study will precisely adhere to the manufacturer's recommendations from the package insert. This entails an initial loading dose of 15 mg/kg followed by four subsequent doses of 10 mg/kg. The dose of fomepizole will not be adjusted based on age, presence of liver injury or renal insufficiency.
RECRUITING
Denver Health and Hospital Authority, Denver
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
INDUSTRY
Richard Dart, MD, PhD
OTHER