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

NCT ID: NCT00643734

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

azithromycin sustained release

Intervention Type DRUG

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

placebo

Intervention Type OTHER

placebo

2

Group Type EXPERIMENTAL

levofloxacin

Intervention Type DRUG

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

placebo

Intervention Type OTHER

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

azithromycin sustained release

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

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

levofloxacin

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

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Mesa, Arizona, United States

Site Status

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

San Luis Obispo, California, United States

Site Status

Pfizer Investigational Site

San Mateo, California, United States

Site Status

Pfizer Investigational Site

Highlands Ranch, Colorado, United States

Site Status

Pfizer Investigational Site

Newark, Delaware, United States

Site Status

Pfizer Investigational Site

Kissimmee, Florida, United States

Site Status

Pfizer Investigational Site

Merrit Island, Florida, United States

Site Status

Pfizer Investigational Site

Evansville, Indiana, United States

Site Status

Pfizer Investigational Site

Evansville, Indiana, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Dubuque, Iowa, United States

Site Status

Pfizer Investigational Site

Pratt, Kansas, United States

Site Status

Pfizer Investigational Site

Madisonville, Kentucky, United States

Site Status

Pfizer Investigational Site

Cumberland, Maryland, United States

Site Status

Pfizer Investigational Site

Kalamazoo, Michigan, United States

Site Status

Pfizer Investigational Site

Olive Branch, Mississippi, United States

Site Status

Pfizer Investigational Site

Elkhorn, Nebraska, United States

Site Status

Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Pfizer Investigational Site

Rio Rancho, New Mexico, United States

Site Status

Pfizer Investigational Site

Charlotte, North Carolina, United States

Site Status

Pfizer Investigational Site

Charlotte, North Carolina, United States

Site Status

Pfizer Investigational Site

Charlotte, North Carolina, United States

Site Status

Pfizer Investigational Site

Hickory, North Carolina, United States

Site Status

Pfizer Investigational Site

Yukon, Oklahoma, United States

Site Status

Pfizer Investigational Site

Downingtown, Pennsylvania, United States

Site Status

Pfizer Investigational Site

King of Prussia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Morrisville, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Greer, South Carolina, United States

Site Status

Pfizer Investigational Site

Dyersburg, Tennessee, United States

Site Status

Pfizer Investigational Site

Lake Jackson, Texas, United States

Site Status

Pfizer Investigational Site

Salt Lake City, Utah, United States

Site Status

Pfizer Investigational Site

Salt Lake City, Utah, United States

Site Status

Pfizer Investigational Site

Walla Walla, Washington, United States

Site Status

Pfizer Investigational Site

Menomonee Falls, Wisconsin, United States

Site Status

Pfizer Investigational Site

Langley, British Columbia, Canada

Site Status

Pfizer Investigational Site

Hawkesbury, Ontario, Canada

Site Status

Pfizer Investigational Site

Kitchener, Ontario, Canada

Site Status

Pfizer Investigational Site

Toronto, Ontario, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Pointe-Claire, Quebec, Canada

Site Status

Pfizer Investigational Site

Ste-foy, Quebec, Canada

Site Status

Pfizer Investigational Site

Victoriaville, Quebec, Canada

Site Status

Pfizer Investigational Site

North Battleford, Saskatchewan, Canada

Site Status

Pfizer Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Pfizer Investigational Site

Providencia, Santiago Metropolitan, Chile

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Indore, Madhya Pradesh, India

Site Status

Pfizer Investigational Site

Mumbai, Maharashtra, India

Site Status

Pfizer Investigational Site

Nagpur, Maharashtra, India

Site Status

Pfizer Investigational Site

Chennai, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Vellore, Tamil Nadu, India

Site Status

Pfizer Investigational Site

Alytus, , Lithuania

Site Status

Pfizer Investigational Site

Kaunas, , Lithuania

Site Status

Pfizer Investigational Site

Klaipėda, , Lithuania

Site Status

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Site Status

Pfizer Investigational Site

San Isidro, Lima region, Peru

Site Status

Pfizer Investigational Site

San Miguel, Lima region, Peru

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Moscow, , Russia

Site Status

Pfizer Investigational Site

Smolensk, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Chile India Lithuania Mexico Peru Russia

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0661103

Identifier Type: -

Identifier Source: org_study_id