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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
ClinicalTrials.gov processed this data on August 23, 2015
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


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: clinical efficacy (cure or marked improvement)

Secondary outcome:

bacteriological efficacy (eradication)

clinical efficacy


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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, 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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2003
Last updated: March 27, 2008

Page last updated: August 23, 2015

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