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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Withdrawn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
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 13, 2009
Last Updated
September 14, 2019
Sponsor
University of Manitoba
Collaborators
Hoffmann-La Roche
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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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