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Trial record 1 of 1 for:    NCT00643734
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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

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ClinicalTrials.gov Identifier: NCT00643734
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : March 26, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 26, 2008
Last Update Posted Date March 26, 2008
Study Start Date  ICMJE April 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Days 14-21) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • laboratory abnormalities [ Time Frame: Baseline and TOC visit ]
  • sponsor assessment of clinical response (cure or failure) in the remaining study populations [ Time Frame: EOT visit and TOC visit ]
  • sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population [ Time Frame: EOT visit and TOC visit ]
  • investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: TOC visit ]
  • sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: End of Treatment (EOT) visit (Days 8-11) ]
  • bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ]
  • sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Days 28-35) ]
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ]
  • adverse events [ Time Frame: Continuous ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
Brief Summary The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • Drug: azithromycin sustained release
    azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
  • Other: placebo
    placebo
  • Drug: levofloxacin
    500 mg (two 250 mg capsules) by mouth once daily for 7 days
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: azithromycin sustained release
    • Other: placebo
  • Experimental: 2
    Interventions:
    • Drug: levofloxacin
    • Other: placebo
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 19, 2008)
468
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.

Exclusion Criteria:

Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Canada,   Chile,   India,   Lithuania,   Mexico,   Peru,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643734
Other Study ID Numbers  ICMJE A0661103
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 Center Pfizer
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