A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00360295
First received: August 3, 2006
Last updated: May 19, 2008
Last verified: May 2008

August 3, 2006
May 19, 2008
September 2006
May 2007   (final data collection date for primary outcome measure)
The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.
The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.
Complete list of historical versions of study NCT00360295 on ClinicalTrials.gov Archive Site
  • Data Review Committee's clinical efficacy (at Day 15 and 29) Investigator's clinical efficacy (at Day 8, 15 and 29), and the tendency toward clinical improvement (at Day 4) Bacteriological efficacy (at Day 4, 8, 15 and 29)
  • Adverse events and safety Laboratory data
  • Endpoints of efficacy are as follows:
  • Data Review Committee’s clinical efficacy (at Day 15 and 29)
  • Investigator’s clinical efficacy (at Day 8, 15 and 29), and the tendency toward clinical improvement (at Day 4)
  • Bacteriological efficacy (at Day 4, 8, 15 and 29)
  • Safety Endpoints: Adverse events and safety Laboratory data
Not Provided
Not Provided
 
A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pneumonia, Community-Acquired
Drug: Azithromycin SR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000)".

Exclusion Criteria:

  • Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. ("Severe" assessed by the Severity of underlying diseases and complications of "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft)" by the Japan Society of Chemotherapy (1997)).
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00360295
A0661174
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2008

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