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Completed

NCT Number: NCT00643227

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

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Tandil, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

clarithromycin extended release (ER)

Drug

7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily

Azithromycin SR

Drug

Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

Primary outcomes

  1. sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population

    Time frame: Test of Cure (TOC) visit (Day 14-21)

Secondary outcomes

  1. bacteriologic response (eradication rate) in the Bacteriological Per Protocol population

    Time frame: TOC visit

  2. investigator assessment of clinical response in the Clinical Per Protocol population

    Time frame: TOC visit

  3. sponsor assessment of clinical response by baseline pathogen

    Time frame: End of Treatment (EOT) visit (Day 8-11) and TOC visit

  4. sponsor assessment of clinical response in the non-primary population

    Time frame: EOT visit and TOC visit

  5. sponsor assessment of clinical responses in the Clinical Per Protocol population

    Time frame: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)

  6. susceptibilities of baseline pathogens

    Time frame: Study endpoint

  7. adverse events

    Time frame: Continuous

  8. vital signs

    Time frame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit

  9. physical examination

    Time frame: Baseline

  10. clinical laboratory assessments (blood chemistry and hematology)

    Time frame: Baseline and TOC visit

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 Clarithromycin Extended Release 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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