Expired Study
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Montgomery, Alabama 36106


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.


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.


Study is Available At:


Original ID:

A0661075


NCT ID:

NCT00643227


Secondary ID:


Study Acronym:


Brief Title:

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneu


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

16 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

504


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:January 2003
Completion Date:March 2004
Completion Type:Actual
Verification Date:March 2008
Last Changed Date:March 19, 2008
First Received Date:March 19, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:clinical laboratory assessments (blood chemistry and hematology)
Time Frame:Baseline and TOC visit
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:physical examination
Time Frame:Baseline
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:vital signs
Time Frame:Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:adverse events
Time Frame:Continuous
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:susceptibilities of baseline pathogens
Time Frame:Study endpoint
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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 Issues:False
Outcome Type:Secondary Outcome
Measure:sponsor assessment of clinical response in the non-primary population
Time Frame:EOT visit and TOC visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:sponsor assessment of clinical response by baseline pathogen
Time Frame:End of Treatment (EOT) visit (Day 8-11) and TOC visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:investigator assessment of clinical response in the Clinical Per Protocol population
Time Frame:TOC visit
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
Time Frame:TOC visit
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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 Issues:False

Study Interventions

Intervention Type:Drug
Name:clarithromycin extended release (ER)
Description:7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
Arm Name:1
Intervention Type:Drug
Name:azithromycin SR
Description:Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Experimental
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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