Overview

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

Status:
Completed

Trial end date:
2003-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Azithromycin
Cefuroxime
Cefuroxime axetil
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate

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