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

Phase 3

Completed

• Conditions: Pneumonia
• Interventions: Drug: cefuroxime plus erythromycin; Drug: azithromycin (Zithromax); Drug: cefuroxime

• Registration Number: NCT00648726
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2003-08
• Status Verified: 2008-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-27
• Last Update Submitted: 2008-03-27
• Study First Posted: 2008-04-01
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	cefuroxime plus erythromycin	-
Arm 2	azithromycin (Zithromax)	-
Arm 3	cefuroxime	-

Primary Outcome Measures

Name	Time	Method
clinical efficacy (cure or marked improvement)	Visit 3 (Day 9 +-1 of treatment)

Secondary Outcome Measures

Name	Time	Method
bacteriological efficacy (eradication)	Visit 3
clinical efficacy	Visit 4 (8 +/-1 days after treatment)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Shanghai, China