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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643734

Enrollment

468

Registered

2008-03-26

Start date

2003-04-30

Completion date

2004-04-30

Last updated

2008-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

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.

Interventions

DRUGazithromycin sustained release

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

OTHERplacebo

placebo

DRUGlevofloxacin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population	Test of Cure (TOC) visit (Days 14-21)

Secondary

Measure	Time frame
sponsor assessment of clinical response (cure or failure) in the remaining study populations	EOT visit and TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population	EOT visit and TOC visit
investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population	TOC visit
laboratory abnormalities	Baseline and TOC visit
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population	TOC visit
summary of baseline susceptibilities	Study endpoint
adverse events	Continuous
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population	End of Treatment (EOT) visit (Days 8-11)

Countries

Canada, Chile, India, Lithuania, Mexico, Peru, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026