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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643227
First Posted: March 26, 2008
Last Update Posted: March 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.

Condition Intervention Phase
Pneumonia Drug: clarithromycin extended release (ER) Drug: azithromycin SR Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Day 14-21) ]

Secondary Outcome Measures:
  • bacteriologic response (eradication rate) in the Bacteriological Per Protocol population [ Time Frame: TOC visit ]
  • investigator assessment of clinical response in the Clinical Per Protocol population [ Time Frame: TOC visit ]
  • sponsor assessment of clinical response by baseline pathogen [ Time Frame: End of Treatment (EOT) visit (Day 8-11) and TOC visit ]
  • sponsor assessment of clinical response in the non-primary population [ Time Frame: EOT visit and TOC visit ]
  • sponsor assessment of clinical responses in the Clinical Per Protocol population [ Time Frame: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35) ]
  • susceptibilities of baseline pathogens [ Time Frame: Study endpoint ]
  • adverse events [ Time Frame: Continuous ]
  • vital signs [ Time Frame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit ]
  • physical examination [ Time Frame: Baseline ]
  • clinical laboratory assessments (blood chemistry and hematology) [ Time Frame: Baseline and TOC visit ]

Enrollment: 504
Study Start Date: January 2003
Study Completion Date: March 2004
Arms Assigned Interventions
Experimental: 1 Drug: clarithromycin extended release (ER)
7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
Experimental: 2 Drug: azithromycin SR
Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).

Exclusion Criteria:

Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643227


  Show 71 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Diretor, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643227     History of Changes
Other Study ID Numbers: A0661075
First Submitted: March 19, 2008
First Posted: March 26, 2008
Last Update Posted: March 26, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors