High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. The illness can range in severity, from mild to severe to even death, and it causes an estimated 500,000 to 1,000,000 deaths worldwide each year. In the last several years, there have been increasing numbers of human cases of avian influenza, or bird flu. This trend may pose a threat of a future pandemic--worldwide outbreak of disease--with an avian influenza virus that can easily spread from person to person. Oseltamivir is an antiviral medication that is used to treat people with uncomplicated human influenza, and it may be effective in treating people with either severe human influenza or avian influenza. The purpose of this international study is to compare standard-dose oseltamivir versus high-dose oseltamivir for treating people who are hospitalized with severe human influenza or avian influenza.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: University of Oxford; Wellcome Trust; World Health Organization
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• At least one of the following respiratory symptoms: cough, dyspnea, sore throat

• Evidence of severe influenza or avian influenza, as defined below

• Severe influenza infection criteria:

1. Need for hospitalization

2. One of the following:

1. New infiltrate on chest x-ray (or any infiltrate if no prior chest x-ray or not known)

2. Severe tachypnea (more information on this criterion can be found in the protocol)

3. Severe dyspnea

4. Arterial oxygen saturation of 92% or less on room air by trans-cutaneous method

3. Positive diagnostic testing for influenza, as defined by either rapid influenza antigen (Ag) positive (A or B) or qualitative reverse transcriptase-polymerase chain reaction (RT-PCR) positive for any influenza

4. Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 10 days before study enrollment

• Avian influenza infection criteria:

1. Nasal wash, nasopharyngeal aspirate, endotracheal aspirate, nasal swab, or throat swab that is RT-PCR positive influenza for H5 influenza

2. Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 14 days before study enrollment

Exclusion Criteria:

• Received more than 72 hours of oseltamivir (six doses) within 14 days

• Received oseltamivir at higher than standard doses within the last 14 days or during current acute illness, whichever is longer

• History of allergy or severe intolerance of oseltamivir, as determined by the investigator

• Alternate explanation for the clinical findings, as determined by the investigator and with the information immediately available

• Creatine clearance less than 10 ml/minute

• Pregnant or breastfeeding