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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643227

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 III

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:

MedlinePlus related topics: Pneumonia

Drug Information available for: Clarithromycin Azithromycin

U.S. FDA Resources

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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 February 09, 2012