A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection

Study Overview
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Brief Summary
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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
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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 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection. The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.

Official Title
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Multicentre, Randomized, Controlled Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As The First Line Treatment For Human Swine Influenza (H1N1) Infection In Designated Flu Clinics During The Pandemic Influenza in Hong Kong

Conditions
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Upper Respiratory Tract Infection, Influenza

Intervention / Treatment
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* Drug: Oseltamivir
* Drug: Zanamivir
* Drug: Placebo of Oseltamivir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oseltamivir<br> | Drug: Oseltamivir<br>* 75 mg twice daily for 5 days<br>* Other names: Tamiflu;|
| Experimental: Zanamivir<br> | Drug: Zanamivir<br>* 10 mg twice daily for 5 days<br>* Other names: Relenza;|
| Placebo Comparator: Placebo of Oseltamivir<br> | Drug: Placebo of Oseltamivir<br>* twice daily for 5 days<br>* Other names: Tamiflu Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to symptoms resolution as reported by the patient |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure including hospitalization due to disease worsening. |  | one week | 
| Viral load |  | one week | 
| Severity of disease as measured by the patient diary and quality of life using SF12v2. |  | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper respiratory tract infection, Influenza A, Human Swine Influenza