Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit
Primary Purpose
Influenza A Virus Infection, Influenza B Virus Infection
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oseltamivir 75 mg
Sponsored by
About this trial
This is an interventional basic science trial for Influenza A Virus Infection focused on measuring Prevention or treatment of influenza in ventilated patients
Eligibility Criteria
Inclusion Criteria:
- patients admitted to the Intensive Care Unit requiring mechanical ventilation due to respiratory failure
- must be within the ages of 18-75 yrs
Exclusion Criteria:
- 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
Sites / Locations
- Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A.Oseltamivir 75 mg dose
B. Oseltamivir 150mg
Arm Description
Patients will be randomized to two groups (group A) to receive oseltamivir at 75 mg, or (group B) to receive the drug at 150 mg in the fasting or fed state.
Patients will be randomized to groups (group A) to receive oseltamivir at 75 mg, or group B to receive the drug at 150 mg in the fasting or fed state.
Outcomes
Primary Outcome Measures
Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults .
Secondary Outcome Measures
Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability.
Full Information
NCT ID
NCT00844155
First Posted
February 13, 2009
Last Updated
September 14, 2019
Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00844155
Brief Title
Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit
Official Title
A Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir (Tamiflu®) in Patients in the Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study has been withdrawn as the H1N1 epidemic made this study redundant
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 treat patients with severe influenza pneumonia, oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults ill with influenza in whom oseltamivir therapy 75 mg BID is efficacious and well tolerated. Additionally, this experiment will test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability. Relative oral bioavailability will be assessed from plasma concentration vs. time over 12 hrs and urinary recovery of drug from 0 to 48 hrs after administration.
Detailed Description
Not required
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A Virus Infection, Influenza B Virus Infection
Keywords
Prevention or treatment of influenza in ventilated patients
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A.Oseltamivir 75 mg dose
Arm Type
Active Comparator
Arm Description
Patients will be randomized to two groups (group A) to receive oseltamivir at 75 mg, or (group B) to receive the drug at 150 mg in the fasting or fed state.
Arm Title
B. Oseltamivir 150mg
Arm Type
Active Comparator
Arm Description
Patients will be randomized to groups (group A) to receive oseltamivir at 75 mg, or group B to receive the drug at 150 mg in the fasting or fed state.
Intervention Type
Drug
Intervention Name(s)
Oseltamivir 75 mg
Other Intervention Name(s)
Tamiflu
Intervention Description
The primary objective of this study is to demonstrate that the pharmacokinetics of oseltamivir, when given enterally to critically ill patients, in the standard treatment dose of 75 mg or double that dose, 150 mg, will yield a plasma concentration - versus - Time Area under the curve (AUC) similar to that observed in adults with influenza treated successfully with a dose of 75 mg, that the disposition characteristics are dose proportionate and are not altered by the concomitant administration of enteral feedings.
Primary Outcome Measure Information:
Title
Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults .
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability.
Time Frame
13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients admitted to the Intensive Care Unit requiring mechanical ventilation due to respiratory failure
must be within the ages of 18-75 yrs
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal Siddiqui, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0Z3
Country
Canada
12. IPD Sharing Statement
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Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit
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