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

This study has been withdrawn prior to enrollment.

(Study has been withdrawn as the H1N1 epidemic made this study redundant)

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by:

University of Manitoba

ClinicalTrials.gov Identifier:

NCT00844155

First received: February 13, 2009

Last updated: April 1, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 13, 2009

Last Updated Date

April 1, 2010

Start Date ^ICMJE

March 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00844155 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir (Tamiflu®) in Patients in the Intensive Care Unit

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Influenza A Virus Infection
Influenza B Virus Infection

Intervention ^ICMJE

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

Study Arm (s)

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.

Intervention: Drug: Oseltamivir 75 mg
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.

Intervention: Drug: Oseltamivir 75 mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00844155

Other Study ID Numbers ^ICMJE

#ML25018, Contract ID # 17908C

Has Data Monitoring Committee

Responsible Party

Faisal Siddiqui MD, University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:

Faisal Siddiqui, MD

University of Manitoba

Information Provided By

University of Manitoba

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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