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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35215 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00643227
Pfizer
Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pneumonia
  • Drug: clarithromycin extended release (ER)
    7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
  • Drug: azithromycin SR
    Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
  • Experimental: 1
    Intervention: Drug: clarithromycin extended release (ER)
  • Experimental: 2
    Intervention: Drug: azithromycin SR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
504
March 2004
Not Provided

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.

Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada,   Estonia,   India,   Lithuania,   Russian Federation,   United States
 
 
NCT00643227
A0661075
No
Not Provided
Not Provided
Diretor, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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