Influenza Pneumonia
Conditions
Interventions
Combination treatment:oseltamivir and cefaclor sustained-release tablets
Antibiotic:cefaclor sustained-release tablets and placebo
anti-influenza:oseltamivir
control:placebo
Sponsors
the First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients fulfill the criteria of community acquired pneumonia, including I or II or III, plus IV. I. New occurrence of cough or expectation, or exacerbation of primary respiratory symptoms, accompanied by chest pain or not; II. Fever; ?. Signs of consolidation in lung or/and rales in lung; ?. Chest X-ray shows new patchy, consolidation, ground glass opacity or interstitial changes, accompanied by plural effusion or not. 2. Patients aged 16 to 65 years. 3. Within 72 hours after onset of illness. 4. CURB-65 score 0. 5. Any of the following detection for pA/H1N1, seasonal influenza A, or seasonal influenza B show positive result: influenza antigen colloidal gold kits, direct immunofluorescence for influenza antigen, or PCR for influenza nucleic acid. 6. Fulfills all of the following bacteria criteria: level of procalcitonin =0.1ng/ml, counts of white blood cell =10*10^9/L, urine streptococcus pneumoniae antigen shows negative, and urine legionella antigen shows negative. 7. Signs the informed consent. 8. No more than two doses of anti microorganism drugs, including anti-influenza drugs or antibiotics.
Exclusion criteria
Exclusion criteria: 1. Patients with chronic pulmonary disease, including COPD, asthma, structural lung disease, such as bronchiectasis or cystic fibrosis, interstitial lung disease, pulmonary atelectasis, pulmonary eosinophilia effusion, pulmonary vasculitis, lung malignancy, et al. 2. Lung infection caused by non-influenza pathogens, such as lung abscess, aspiration pneumonia, obstructive pneumonia, lung tuberculosis, pulmonary fungal disease, et al. 3. Chronic organ failure, such as heart, renal or liver failure. 4. Severe influenza, defined as fulfill any of the following symptoms or signs: I. disorder of consciousness; II. dyspnea or rate of respiration >30/min or die blausucht; III. serious omitting, diarrhea, accompanied by signs of dehydration; IV. volume of urine less than 400ml per 24 hours or acute renal failure; V. blood pressure less than 90/60mmHg; VI. SpO2 <90% or PaO2<60mmHg or oxygen index(OI)<300mmHg after rest for more than 30 minutes; VII. X-rays shows bilateral or multi-lobes infiltration or infiltration enlarges =50% within 48 hours after enrolment; VIII. level of creatine kinase and its isoenzymes elevates rapidly; IX. underlying diseases exacerbate obviously and turn to organ dysfunction or failure. 5. Patients in immunosuppression, including immunodeficiency disease such as AIDS, organ transplantation or hematopoietic stem cell transplantation, continuous use of any dose systemic corticosteroid for more than two weeks within 3 months, immunosuppressive treatment such as methotrexate, azathioprine, cyclosporine or cyclophosphamide et al, malignancy or anti-cancer treatment is ongoing. 6. Patients admit to hospital again within 14 days after discharge from hospital. 7. Pregnant or lactating women. 8. Patients joined similar study before or is unwilling to provide illness history or denies to sign the informed consent. 9. Patients received antibiotics for more than 1 week within one month. 10. Patients who are in risk of developing complicated influenza, such as body mass index =30. 11. Patients report allergy history to oseltamivir capsule or its excipients, penicillin or ephalosporins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total effect; | — |
Secondary
| Measure | Time frame |
|---|---|
| virus titre;clinical effect;radiologic effect;symptom score;frequency of use in antipyretic;frequency of treatment in cough;rate of second bacteria infection;complication of influenza;economic evaluation; | — |
Countries
China
Contacts
Public ContactRongchang Chen
the First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed