An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: cefuroxime plus erythromycin (Drug); azithromycin (Zithromax) (Drug); cefuroxime (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: clinical efficacy (cure or marked improvement)
Secondary outcome: bacteriological efficacy (eradication)clinical efficacy
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, SHANGHAI 200025, China
Pfizer Investigational Site, BEIJING 100853, China
Pfizer Investigational Site, SHANGHAI 200003, China
Pfizer Investigational Site, SHANGHAI 200080, China
Pfizer Investigational Site, SHANGHAI 200040, China
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2003
Ending date: August 2003
Last updated: March 27, 2008
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