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

Information source: University of Manitoba
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza A Virus Infection; Influenza B Virus Infection

Intervention: Oseltamivir 75 mg (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: University of Manitoba

Official(s) and/or principal investigator(s):
Faisal Siddiqui, MD, Principal Investigator, Affiliation: University of Manitoba

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.

Clinical Details

Official title: A Study of the Relative Oral Bioavailability of the Antiflu Medicine Oseltamivir (TamifluŽ) in Patients in the Intensive Care Unit

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

Primary outcome: Oseltamivir administered enterally via nasogastric tube, with and without concomitant food or alimentation, will have similar oral bioavailability to that observed in ambulatory adults .

Secondary outcome: Test the hypothesis that increasing the dose (150 mg), with and without concomitant enteral feeding, will show a proportionate increase in bioavailability.

Detailed description: Not required

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Health Sciences Centre, Winnipeg, Manitoba R3E 0Z3, Canada
Additional Information

Starting date: March 2009
Last updated: April 1, 2010

Page last updated: August 23, 2015

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