A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients (MACH)
The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Minocycline in Acute Cerebral Hemorrhage (MACH) Trial|
- modified Rankin Scale [ Time Frame: 90 days ] [ Designated as safety issue: No ]A blinded assessor will perform the modified Rankin Scale after 90 days to determine functional outcome. This will serve as our efficacy endpoint.
- Safety Assessment [ Time Frame: 90 days ] [ Designated as safety issue: No ]Adverse events will be asses for 90 days. This will serve as our safety endpoint.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.
This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 6-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.
Other Name: Dynacin, Minocin
No Intervention: Control
This arm will not receive any minocycline. This arm will receive standard of care treatment.
MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subsequent doses will be given orally every 24 hours for a total of five doses. The study will test to see if the medication is safe in intracerebral hemorrhage. The pharmacokinetics of minocycline in intracerebral hemorrhage will be determined and the impact of minocycline on blood biomarkers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805895
|Contact: Jeffrey A Switzer, DOemail@example.com|
|Contact: Mary Anne Park, RNfirstname.lastname@example.org|
|United States, Georgia|
|Georgia Health Sciences University||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Jeffrey Switzer, DO 706-721-1691 email@example.com|
|Principal Investigator: Jeffrey Switzer, DO|
|Sub-Investigator: David Hess, MD|
|Sub-Investigator: Askiel Bruno, MD|
|Sub-Investigator: Fenwick Nichols, MD|
|Sub-Investigator: Hartmut Gross, MD|
|Sub-Investigator: Susan Fagan, PharmD|
|Principal Investigator:||Jeffrey A Switzer, DO||Georgia Regents University|