Pneumonia Clinical Trial
Official title:
An Open, Prospective, Randomized, Multi-Center Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin vs. Cefuroxime Monotherapy or Plus Oral Erythromycin for the Treatment of Chinese Hospitalized Patients With Community- Acquired Pneumonia
Verified date | March 2008 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
To validate the efficacy and safety of azithromycin for the treatment of Chinese patients hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the combination of cefuroxime plus oral erythromycin.
Status | Completed |
Enrollment | 139 |
Est. completion date | August 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: Inclusion Criteria: - Patients hospitalized with a diagnosis of community acquired pneumonia (CAP) as defined by the presence of new infiltrate(s) including manifestation of consolidation, patchy, diffuse or interstitial inflammation on chest X-ray with or without pleural effusion plus at least 1 of the following: new cough and expectoration or progression of respiratory symptoms with purulent sputum with or without chest pain; fever; auscultatory findings such as rales or evidence of pulmonary consolidation; blood leukocyte count >10×109/L or <4×109/L with or without >15% bands or a blood leukocyte count between 4 and 10 with neutropils greater than or equal to 75% Exclusion Criteria: Exclusion Criteria: - Patients with hospital acquired pneumonia, aspiration pneumonia, severe pneumonia, history of post-obstructive pneumonia, active tuberculosis or bronchitis, bronchiectasis or chronic obstructive pulmonary disease without evidence of acute infection were not eligible for this study - Patients treated with any systemic antibiotic within 72 hours prior to study entry were not eligible unless the medication was, in the opinion of the investigators, classified as having failed |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Pfizer Investigational Site | Beijing | |
China | Pfizer Investigational Site | Shanghai | |
China | Pfizer Investigational Site | Shanghai | |
China | Pfizer Investigational Site | Shanghai | |
China | Pfizer Investigational Site | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical efficacy (cure or marked improvement) | Visit 3 (Day 9 +-1 of treatment) | No | |
Secondary | bacteriological efficacy (eradication) | Visit 3 | No | |
Secondary | clinical efficacy | Visit 4 (8 +/-1 days after treatment) | No |
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