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

Influenza A Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00844155
• Other study ID #: #ML25018
• Secondary ID: Contract ID # 17
• Status: Withdrawn
• Phase: N/A
• Start date: March 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2019
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not required

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Herpesviridae Infections
• Infection
• Influenza A Virus Infection
• Influenza B Virus Infection
• Influenza, Human
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability.		13 months