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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00648726

Purpose

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.

Condition	Intervention	Phase
Pneumonia	Drug: cefuroxime plus erythromycin Drug: azithromycin (Zithromax) Drug: cefuroxime	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Erythromycin Gluceptate Cefuroxime Cefuroxime sodium Cefuroxime axetil Azithromycin Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

clinical efficacy (cure or marked improvement) [ Time Frame: Visit 3 (Day 9 +-1 of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

bacteriological efficacy (eradication) [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
clinical efficacy [ Time Frame: Visit 4 (8 +/-1 days after treatment) ] [ Designated as safety issue: No ]

Enrollment:	139
Study Start Date:	January 2003
Study Completion Date:	August 2003

Arms	Assigned Interventions
Arm 1: Active Comparator	Drug: cefuroxime plus erythromycin 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
Arm 2: Active Comparator	Drug: azithromycin (Zithromax) 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
Arm 3: Active Comparator	Drug: cefuroxime 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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648726

Locations

China
Pfizer Investigational Site
SHANGHAI, China, 200025
Pfizer Investigational Site
BEIJING, China, 100853
Pfizer Investigational Site
SHANGHAI, China, 200003
Pfizer Investigational Site
SHANGHAI, China, 200080
Pfizer Investigational Site
SHANGHAI, China, 200040

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661104
Study First Received:	March 27, 2008
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00648726 History of Changes
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Erythromycin stearate
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Enzyme Inhibitors
Erythromycin
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents

Cefuroxime
Cefuroxime axetil
Respiratory Tract Diseases
Respiratory Tract Infections
Erythromycin Estolate
Therapeutic Uses
Lung Diseases
Azithromycin
Pneumonia

ClinicalTrials.gov processed this record on February 08, 2010