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

Pfizer468 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

468

Conditions

Pneumonia

Interventions

azithromycin sustained releaseDRUG

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

placeboOTHER

placebo

levofloxacinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (65)

Outcomes

Primary Outcomes

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

laboratory abnormalities

Time frame: Baseline and TOC visit

sponsor assessment of clinical response (cure or failure) in the remaining study populations

Time frame: EOT visit and TOC visit

sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population

Time frame: EOT visit and TOC visit

investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population

Time frame: TOC visit

sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population

Time frame: End of Treatment (EOT) visit (Days 8-11)

bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population

Time frame: TOC visit

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)

summary of baseline susceptibilities

Time frame: Study endpoint

adverse events

Time frame: Continuous

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pfizer Investigational Site

Mesa, Arizona, United States

Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

San Luis Obispo, California, United States

Pfizer Investigational Site

San Mateo, California, United States

Pfizer Investigational Site

Highlands Ranch, Colorado, United States

Pfizer Investigational Site

Newark, Delaware, United States

Pfizer Investigational Site

Kissimmee, Florida, United States

Pfizer Investigational Site

Merrit Island, Florida, United States

Pfizer Investigational Site

Evansville, Indiana, United States

Pfizer Investigational Site

Evansville, Indiana, United States

...and 55 more locations