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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00643734
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : March 26, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: azithromycin sustained release Other: placebo Drug: levofloxacin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
Study Start Date : April 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: 1 Drug: azithromycin sustained release
azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose

Other: placebo
placebo

Experimental: 2 Drug: levofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days

Other: placebo
placebo




Primary Outcome Measures :
  1. sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Days 14-21) ]

Secondary Outcome Measures :
  1. laboratory abnormalities [ Time Frame: Baseline and TOC visit ]
  2. sponsor assessment of clinical response (cure or failure) in the remaining study populations [ Time Frame: EOT visit and TOC visit ]
  3. sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population [ Time Frame: EOT visit and TOC visit ]
  4. investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: TOC visit ]
  5. sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: End of Treatment (EOT) visit (Days 8-11) ]
  6. bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ]
  7. sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Days 28-35) ]
  8. summary of baseline susceptibilities [ Time Frame: Study endpoint ]
  9. adverse events [ Time Frame: Continuous ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.

Exclusion Criteria:

Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643734


Locations
Show Show 65 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00643734    
Other Study ID Numbers: A0661103
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: March 26, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors