Upper Respiratory Tract Infection, Influenza
Conditions
Keywords
Upper respiratory tract infection, Influenza A, Human Swine Influenza
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 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.
Interventions
DRUGOseltamivir
75 mg twice daily for 5 days
DRUGZanamivir
10 mg twice daily for 5 days
DRUGPlacebo of Oseltamivir
twice daily for 5 days
Sponsors
Food and Health Bureau, Hong Kong
Hospital Authority
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to symptoms resolution as reported by the patient | one week |
Secondary
| Measure | Time frame |
|---|---|
| Severity of disease as measured by the patient diary and quality of life using SF12v2. | one week |
| Treatment failure including hospitalization due to disease worsening. | one week |
| Viral load | one week |
Countries
China, Hong Kong
Outcome results
None listed