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Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir in the Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT00844155
Recruitment Status : Withdrawn (Study has been withdrawn as the H1N1 epidemic made this study redundant)
First Posted : February 16, 2009
Last Update Posted : April 2, 2010
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Manitoba

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.

Condition or disease Intervention/treatment
Influenza A Virus Infection Influenza B Virus Infection Drug: Oseltamivir 75 mg

Detailed Description:
Not required

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir (Tamiflu®) in Patients in the Intensive Care Unit
Study Start Date : March 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A.Oseltamivir 75 mg dose
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.
Drug: Oseltamivir 75 mg
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.
Other Name: Tamiflu
Active Comparator: B. Oseltamivir 150mg
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.
Drug: Oseltamivir 75 mg
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.
Other Name: Tamiflu



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844155


Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3E 0Z3
Sponsors and Collaborators
University of Manitoba
Hoffmann-La Roche
Investigators
Principal Investigator: Faisal Siddiqui, MD University of Manitoba

Responsible Party: Faisal Siddiqui MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT00844155     History of Changes
Other Study ID Numbers: #ML25018
Contract ID # 17908C
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: April 2, 2010
Last Verified: February 2010

Keywords provided by University of Manitoba:
Prevention or treatment of influenza in ventilated patients

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action