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
1 other identifier
interventional
139
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2003
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 27, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedApril 1, 2008
March 1, 2008
March 27, 2008
March 27, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
clinical efficacy (cure or marked improvement)
Visit 3 (Day 9 +-1 of treatment)
Secondary Outcomes (2)
bacteriological efficacy (eradication)
Visit 3
clinical efficacy
Visit 4 (8 +/-1 days after treatment)
Study Arms (3)
Arm 1
ACTIVE COMPARATORArm 2
ACTIVE COMPARATORArm 3
ACTIVE COMPARATORInterventions
intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days plus erythromycin ethylsuccinate 0.5 g twice daily, which was given for a total duration of 14 days for subjects with suspected pneumonia due to atypical pathogens
intravenous azithromycin 500 mg once daily for 4 +/-1 days, followed by oral azithromycin 500 mg once daily for a total duration of 9 +/-1 days
intravenous cefuroxime 1.5 g twice daily for 4 +/-1 days, followed by oral cefuroxime 0.5 g twice daily for a total duration of 9 +/-1 days
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (5)
Pfizer Investigational Site
Beijing, 100853, China
Pfizer Investigational Site
Shanghai, 200003, China
Pfizer Investigational Site
Shanghai, 200025, China
Pfizer Investigational Site
Shanghai, 200040, China
Pfizer Investigational Site
Shanghai, 200080, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 27, 2008
First Posted
April 1, 2008
Study Start
January 1, 2003
Study Completion
August 1, 2003
Last Updated
April 1, 2008
Record last verified: 2008-03