Status:
WITHDRAWN
Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Influenza A Virus Infection
Influenza B Virus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This proposed pharmacokinetic study will test the hypothesis that in critically ill patients with respiratory failure requiring mechanical ventilation such as might be anticipated to be needed to trea...
Detailed Description
Not required
Eligibility Criteria
Inclusion
- patients admitted to the Intensive Care Unit requiring mechanical ventilation due to respiratory failure
- must be within the ages of 18-75 yrs
Exclusion
- patients unable to have enteral feeding
- intolerance to oseltamivir
- pregnancy
- gastrointestinal or malabsorptive disease
- intestinal bypass surgery
- diarrhea (\>2 loose bowel movements per day)
- receipt of prokinetic medications (metoclopramide, domperidone, erythromycin)
- severe liver disease (hepatocellular enzymes \> 3 times the upper limit of normal)
- renal failure (Cockroft-Gault Creatinine Clearance \< 30 ml/min, Dialysis dependant)
- cystic fibrosis
- intoxication or drug overdose
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00844155
Start Date
March 1 2009
End Date
July 1 2009
Last Update
September 17 2019
Active Locations (1)
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1
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3E 0Z3