High dose versus standard dose oseltamivir for the treatment of severe influenza and avian influenza

Phase 2

Completed

• Conditions: Influenza in birds, severe influenza; Infections and Infestations; Influenza

• Registration Number: ISRCTN43083885
• Lead Sponsor: ational Institute of Allergy and Infectious Diseases (NIAID) (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-12
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

1. Age greater than or equal to one year (National Institutes of Health [NIH] site specific: age greater than or equal to 18 years old)
2. Fever greater than or equal to 38.0 degrees Celsius
3. At least one respiratory symptom:
3.1. Cough
3.2. Dyspnea (shortness of breath)
3.3. Sore throat
4. Illness (onset of fever, respiratory symptoms, or constitutional symptoms) began in the last seven days
5. Have evidence of severe respiratory disease from influenza or avian influenza as defined below (A or B):

A. Evidence of severe influenza infection:
a. Need for hospitalisation (as determined by investigator or clinician)
b. One of the following (all criteria as judged by the investigator):
i. New infiltrate on chest x-ray (or any infiltrate if no prior chest x-ray or not known)
ii. Severe tachypnea (defined as: respiratory rate greater than or equal to 30 for age greater than or equal to 12 years, rate greater than or equal to 40 for age 6 - 12 years, rate greater than or equal to 45 for age 3 - 6 years, rate greater than or equal to 50 for age 1 - 3 years)
iii. Severe dyspnea (unable to speak full sentences, or use of accessory respiratory muscles)
iv. Arterial oxygen saturation less than 92% on room air measured by trans-cutaneous method
AND
c. Positive diagnostic testing for influenza defined as:
d. Rapid influenza Ag positive (A or B)
e. Qualitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) positive for influenza (any)

B. Evidence of avian influenza infection
a. Nasal wash, nasal swab, or throat swab that is RT-PCR positive for H5 influenza
AND
b. NIH site-specific

6. Willingness to have bloods stored

Exclusion Criteria

1. Pregnancy or urine beta-human Chorionic Gonadotropin (beta-hCG) positive
2. Active breast feeding
3. Receipt of more than 72 hours of oseltamivir within the last week
4. Receipt of oseltamivir at higher than standard doses (75 mg twice daily [bid], or equivalent dose adjusted for age, weight and creatinine clearance) within the last 14 days or during this acute illness, whichever is longer
5. History of allergy or severe intolerance (as judged by the investigator) of oseltamivir
6. Alternate explanation for the clinical findings as determined by the investigator with the information immediately available
7. Creatinine (Cr) Clearance (estimated by serum Cr) of less than 10 ml/min

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to compare the antiviral efficacy of standard and high-dose oseltamivir in the treatment of severe influenza infections as assessed by negative reverse transcriptase (RT)-PCR for viral RNA in nose and throat swabs at day 5.