Antiviral and Chinese Medicinal Herbs Treatment on Novel Influenza A (H1N1) Virus Pneumonia: Multi-centre, Prospective, Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- oseltamivir
- Conditions
- Influenza
- Sponsor
- Capital Medical University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of the study is to determine whether the combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.
Detailed Description
The antiviral agent, oseltamivir, is recommended by the World Health Organization (WHO) to treat recent outbreak novel influenza A (H1N1) virus infection around world. But limited stock and resistant strain emergence raised increasing concerns. Chinese medicinal herbs, are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. The investigators performed RCT to indicate that a combination treatment of Chinese medicinal herbs and oseltamivir is more effective than single oseltamivir in treating novel influenza A (H1N1) pneumonia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed novel influenza A(H1N1) case with laboratory evidence
- •70 ys ≥ age ≥14ys
- •Within 72hr after the onset of symptoms(body temperature≥37.5℃ with at least one respiratory symptom (cough, sore throat, or nasal symptom)
- •New lung infiltration showed by chest radiology(x-ray or CT)
Exclusion Criteria
- •Age\<14ys or \>70ys
- •Pregnancy
- •Severe chronic underlying diseases: severe COPD(FEV1/EVC \<70% and FEV1 \<30% predicted or respiratory failure or congestive heart failure), severe liver disfunction（ALT or AST ≥3 times normal elevation), renal disfunction（Cr\>2mg/dL), chronic heart failure(NYHA Ⅲ-Ⅳ grade）
- •Immunocompromised patients(cancer, organ transplant, AIDS and a history of treatment with immunosuppressive drug and glucocorticoids in the past 3 months)
- •Taken Chinese medicinal herbs, antiviral or antibiotic drug in the past 2 weeks
- •Inoculation influenza vaccination
- •One of the following items appeared at the enrollment
- •respiratory failure：PaO2\<60mmHg and/or PCO2\>50mmHg or PaO2/FiO2≤300
- •circulation failure: despite adequate fluid resuscitation and cardiac output, systolic \<90mmHg or requirement inotropic support
- •renal function failure: despite adequate fluid resuscitation and cardiac output, urine ≤ 0.5ml/kg.h, Cr or BUN≥1 time normal elevation
Arms & Interventions
oseltamivir
single antiviral treatment
Intervention: oseltamivir
oseltimivir and chinese medicinal herbs
combination treatment
Intervention: oseltamivir and chinese medicinal herbs
Outcomes
Primary Outcomes
Efficacy rate in 5 days (defined as failure: SaO2<90% at room air or temperature elevated continuously)
Time Frame: two years
Secondary Outcomes
- Time to resolution of fever(defined as the period from start of study-drug to relief of fever)(two years)
- Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)(two years)
- Virus shedding time(two years)
- Infiltration resolution of chest radiology(two years)
- SaO2 and PaO2/FiO2(arterial blood gas)(two years)