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

Not Applicable

Withdrawn

• Conditions: Influenza A Virus Infection; Influenza B Virus Infection
• Interventions: Drug: Oseltamivir 75 mg

• Registration Number: NCT00844155
• Lead Sponsor: 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.

Detailed Description

Not required

Study Timeline

• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Start: 2009-03
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-14
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A.Oseltamivir 75 mg dose	Oseltamivir 75 mg	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.
B. Oseltamivir 150mg	Oseltamivir 75 mg	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.

Primary Outcome Measures

Name	Time	Method
Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults .	13 months

Secondary Outcome Measures

Name	Time	Method
Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability.	13 months

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada