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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014