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

Pfizer1 site504 target enrollmentJanuary 2003

ConditionsPneumonia

Interventionsclarithromycin extended release (ER)azithromycin SR

Drugsclarithromycin extended release (ER)azithromycin SR

Overview

Phase: Phase 3
Intervention: clarithromycin extended release (ER)
Conditions: Pneumonia
Sponsor: Pfizer
Enrollment: 504
Locations: 1
Primary Endpoint: sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

March 2004

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility 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.

Arms & Interventions

1

Intervention: clarithromycin extended release (ER)

2

Intervention: azithromycin SR

Outcomes

Primary Outcomes

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 Outcomes

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