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

NCT00648726

Last updated date
Study Location
Pfizer Investigational Site
Beijing, , 100853, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: cefuroxime plus erythromycin
  • Active Comparator: Arm 2
    Intervention: Drug: azithromycin (Zithromax)
  • Active Comparator: Arm 3
    Intervention: Drug: cefuroxime
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2008)
139
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00648726
Other Study ID Numbers  ICMJE A0661104
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP