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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

NCT00643734 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2008-03-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

azithromycin sustained release

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

OTHER

placebo

placebo

DRUG

levofloxacin

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

OTHER

placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Completion
2004-04-30

Countries

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643734 on ClinicalTrials.gov