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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 December 5, 2019

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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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Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia
NCT04040621
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0+
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Multiple Sites
Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: clarithromycin extended release (ER)
  • Experimental: 2
    Intervention: Drug: azithromycin SR
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2008)
504
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Estonia,   India,   Lithuania,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643227
Other Study ID Numbers  ICMJE A0661075
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDiretor, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2008

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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