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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643227
First received: March 19, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643227

  Show 72 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Diretor, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643227     History of Changes
Other Study ID Numbers: A0661075
Study First Received: March 19, 2008
Last Updated: March 19, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014