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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00648726
First received: March 27, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
Erythromycin stearate
Erythromycin ethylsuccinate
Erythromycin phosphate
Cefuroxime
Cefuroxime sodium
Cefuroxime axetil
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
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 |
|---|---|
| Active Comparator: Arm 1 |
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
|
| Active Comparator: Arm 2 |
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
|
| Active Comparator: Arm 3 |
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:
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648726
Locations
| China | |
| Pfizer Investigational Site | |
| Beijing, China, 100853 | |
| Pfizer Investigational Site | |
| Shanghai, China, 200025 | |
| 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:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00648726 History of Changes |
| Other Study ID Numbers: | A0661104 |
| Study First Received: | March 27, 2008 |
| Last Updated: | March 27, 2008 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Cefuroxime Cefuroxime axetil Erythromycin Erythromycin Estolate Erythromycin Ethylsuccinate Erythromycin stearate |
Azithromycin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013