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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643734

Purpose

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	Intervention	Phase
Pneumonia	Drug: azithromycin sustained release Other: placebo Drug: levofloxacin	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Ofloxacin Azithromycin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: Test of Cure (TOC) visit (Days 14-21) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

laboratory abnormalities [ Time Frame: Baseline and TOC visit ] [ Designated as safety issue: Yes ]
sponsor assessment of clinical response (cure or failure) in the remaining study populations [ Time Frame: EOT visit and TOC visit ] [ Designated as safety issue: No ]
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population [ Time Frame: EOT visit and TOC visit ] [ Designated as safety issue: No ]
investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [ Time Frame: End of Treatment (EOT) visit (Days 8-11) ] [ Designated as safety issue: No ]
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
summary of baseline susceptibilities [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Enrollment:	468
Study Start Date:	April 2003
Study Completion Date:	April 2004

Arms	Assigned Interventions
1: Experimental	Drug: azithromycin sustained release azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose Other: placebo placebo
2: Experimental	Drug: levofloxacin 500 mg (two 250 mg capsules) by mouth once daily for 7 days Other: placebo placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643734

Show 69 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661103
Study First Received:	March 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00643734 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Azithromycin

Lung Diseases
Ofloxacin
Anti-Infective Agents, Urinary
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents
Pharmacologic Actions
Anti-Bacterial Agents

Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Azithromycin
Therapeutic Uses
Pneumonia
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009