Status:
COMPLETED
High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Wellcome Trust
World Health Organization
Conditions:
Influenza
Avian Influenza
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief 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,...
Detailed Description
Two main types of influenza virus--Types A and B--are responsible for the seasonal flu epidemics that occur each year. The influenza A viruses can be broken down into subtypes based on two proteins on...
Eligibility Criteria
Inclusion
- 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:
- Need for hospitalization
- One of the following:
- New infiltrate on chest x-ray (or any infiltrate if no prior chest x-ray or not known)
- Severe tachypnea (more information on this criterion can be found in the protocol)
- Severe dyspnea
- Arterial oxygen saturation of 92% or less on room air by trans-cutaneous method
- 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
- Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 10 days before study enrollment
- Avian influenza infection criteria:
- Nasal wash, nasopharyngeal aspirate, endotracheal aspirate, nasal swab, or throat swab that is RT-PCR positive influenza for H5 influenza
- Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 14 days before study enrollment
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00298233
Start Date
February 1 2006
End Date
January 1 2010
Last Update
June 6 2014
Active Locations (12)
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1
Changi General Hospital
Singapore, Singapore
2
National University Hospital, National University of Singapore
Singapore, Singapore
3
Tan Tock Seng Hospital
Singapore, Singapore
4
Queen Sirikit National Institute of Child Health
Bangkok, Thailand