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Completed

NCT Number: NCT00643734

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 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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Langley, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

azithromycin sustained release

Drug

azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose

Placebo

Other

placebo

Levofloxacin

Drug

500 mg (two 250 mg capsules) by mouth once daily for 7 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 26, 2008
Registry last updated
Mar 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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