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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: clarithromycin extended release (ER)
  • 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
• Drug: azithromycin SR
  • Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary 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)
    Safety Issue?: No

Secondary Measures

• bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• investigator assessment of clinical response in the Clinical Per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• sponsor assessment of clinical response by baseline pathogen
  • Time Frame: End of Treatment (EOT) visit (Day 8-11) and TOC visit
    Safety Issue?: No
• sponsor assessment of clinical response in the non-primary population
  • Time Frame: EOT visit and TOC visit
    Safety Issue?: No
• 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)
    Safety Issue?: No
• susceptibilities of baseline pathogens
  • Time Frame: Study endpoint
    Safety Issue?: No
• adverse events
  • Time Frame: Continuous
    Safety Issue?: Yes
• vital signs
  • Time Frame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
    Safety Issue?: Yes
• physical examination
  • Time Frame: Baseline
    Safety Issue?: Yes
• clinical laboratory assessments (blood chemistry and hematology)
  • Time Frame: Baseline and TOC visit
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643227

Study ID Number: A0661075

ClinicalTrials.gov Identifier: NCT00643227

Health Authority: United States: Food and Drug Administration

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