Status:
TERMINATED
A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Food and Health Bureau, Hong Kong
Hospital Authority
Conditions:
Upper Respiratory Tract Infection
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.
Detailed Description
The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of ...
Eligibility Criteria
Inclusion
- Male or female patients 18 years or older with body weight \>40kg
- Written informed consent
- Presented within 48 hours of onset of influenza-like illness
- Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:
- Clinical criteria
- Fever \>38 oC (Infrared Forehead Thermometer will be used to measure the Temporal Artery Temperature under the skin) AND
- At least one upper respiratory tract infection (cough, running nose, sore throat)
- Laboratory criteria Positive rapid test result for influenza A (by Influenza Rapid Diagnostic test) within 48 hours of onset of flu-like symptoms
Exclusion
- Age below 18 years
- Persons who lack the ability to care for themselves
- Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
- Pregnancy or lactation
- Coexisting liver disease
- Coexisting cardiovascular disease except stable hypertension without complication
- Coexisting chronic pulmonary disease
- Coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies
- Renal failure
- Terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months
- Known intolerance to oseltamivir or zanamivir
- Known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those
- Subjects who have received oseltamivir as prophylaxis for H1N1 infection
- Subjects who have received any investigational drug within 1 month prior to study entry
- Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00979667
Start Date
October 1 2009
End Date
October 1 2010
Last Update
April 11 2011
Active Locations (3)
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1
Shau Kei Wan Jockey Club Clinic
Hong Kong, Hong Kong, China, 852
2
Fanling Family Medicine Centre
Hong Kong, Hong Kong
3
Sai Ying Pun Jockey Club General Outpatient Clinic
Hong Kong, Hong Kong