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

University of Manitoba

Status: Withdrawn

Conditions: Influenza B Virus Infection; Influenza A Virus Infection

Treatments: Drug: Oseltamivir 75 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00844155

Contract ID # 17908C

#ML25018

Details and patient eligibility

About

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.

Full description

Not required

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A.Oseltamivir 75 mg dose

Active Comparator group

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.

Treatment:

Drug: Oseltamivir 75 mg

B. Oseltamivir 150mg

Active Comparator group

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.

Treatment:

Drug: Oseltamivir 75 mg