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

NCT ID: NCT00844155

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-07-31

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

Conditions

Influenza A Virus Infection; Influenza B Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oseltamivir 75 mg

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Oseltamivir 75 mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Tamiflu

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Dr. Faisal Siddiqui

Principal Investigator MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faisal Siddiqui, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health Sciences Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

Contract ID # 17908C

Identifier Type: -

Identifier Source: secondary_id

#ML25018

Identifier Type: -

Identifier Source: org_study_id