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

This study has been completed.
Sponsor:
Collaborators:
Wellcome Trust
World Health Organization
University of Oxford
Information provided by (Responsible Party):
Jeremy Farrar, Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT00298233
First received: March 1, 2006
Last updated: May 26, 2014
Last verified: May 2014
Results First Received: January 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Influenza
Avian Influenza
Severe Influenza
Intervention: Drug: Oseltamivir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Standard Dose Oseltamivir Adult Cohort All participants >= 15 years received standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
Double Dose Oseltamivir Adult Cohort All Participants >= 15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
Standard Dose Oseltamivir Child Cohort All participants <15 years received standard dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
Double Dose Oseltamivir Child Cohort All Participants <15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.

Participant Flow:   Overall Study
    Standard Dose Oseltamivir Adult Cohort     Double Dose Oseltamivir Adult Cohort     Standard Dose Oseltamivir Child Cohort     Double Dose Oseltamivir Child Cohort  
STARTED     39     41     122     124  
COMPLETED     39     41     122     124  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants that were randomized

Reporting Groups
  Description
Standarad Dose Oseltamivir All participants that were randomized and received standard dose oseltamivir
Double Dose Oseltamivir All participants that were randomized and received doubledose oseltamivir
Total Total of all reporting groups

Baseline Measures
    Standarad Dose Oseltamivir     Double Dose Oseltamivir     Total  
Number of Participants  
[units: participants]
  161     165     326  
Age, Customized  
[units: participants]
     
Child cohort: ≥1 to <15 years     122     124     246  
Adult cohort: ≥15 years     39     41     80  
Gender  
[units: participants]
     
Female     72     69     141  
Male     89     96     185  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of All Participants Negative for Viral RNA on Day 5   [ Time Frame: After 5 days of treatment ]

2.  Secondary:   Participants Meeting Criteria for Day 5 Clinical Failure   [ Time Frame: After 5 days of treatment ]

3.  Secondary:   In-hospital Mortality Rates   [ Time Frame: After up to 10 days of treatment ]

4.  Secondary:   Median Time (Days) Receipt of Oxygen   [ Time Frame: Throughout study, 14 days ]

5.  Secondary:   Median Time (Days) in ICU   [ Time Frame: Throughout study, 14 days ]

6.  Secondary:   Median Time (Days) on Ventilation   [ Time Frame: Throughout study, 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jeremy Farrar
Organization: Oxford University Clinical Research Unit
phone: +84 839237954
e-mail: info@oucru.org


Publications of Results:
Other Publications:

Responsible Party: Jeremy Farrar, Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT00298233     History of Changes
Other Study ID Numbers: SEA 001, N01A050042
Study First Received: March 1, 2006
Results First Received: January 17, 2014
Last Updated: May 26, 2014
Health Authority: United States: Food and Drug Administration