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 | Completed Phase 3

• 1 other identifier: A0661103
• Study Type: interventional
• Target: 468
• Locations: 8 countries
• Sites: 65

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

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

  Test of Cure (TOC) visit (Days 14-21)

Secondary Outcomes (9)

• laboratory abnormalities

  Baseline and TOC visit

• 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

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

  End of Treatment (EOT) visit (Days 8-11)

Study Arms (2)

1

EXPERIMENTAL

Drug: azithromycin sustained release; Other: placebo

2

EXPERIMENTAL

Drug: levofloxacin; Other: placebo

Interventions

azithromycin sustained release DRUG

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

1

placebo OTHER

placebo

1

levofloxacin DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (65)

Pfizer Investigational Site

Mesa, Arizona, 85206, United States

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Phoenix, Arizona, 85014, United States

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San Luis Obispo, California, 93401, United States

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San Mateo, California, 94403, United States

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Highlands Ranch, Colorado, 80130, United States

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Newark, Delaware, 19702, United States

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Kissimmee, Florida, 34741, United States

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Merrit Island, Florida, 32953, United States

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Evansville, Indiana, 47712, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46254, United States

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Dubuque, Iowa, 52001, United States

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Pratt, Kansas, 67124, United States

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Madisonville, Kentucky, 42431, United States

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Cumberland, Maryland, 21502, United States

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Kalamazoo, Michigan, 49009, United States

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Olive Branch, Mississippi, 38654, United States

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Elkhorn, Nebraska, 68022, United States

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Omaha, Nebraska, 68144, United States

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Rio Rancho, New Mexico, 87124, United States

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Charlotte, North Carolina, 28209, United States

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Charlotte, North Carolina, 28210, United States

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Charlotte, North Carolina, 28262, United States

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Hickory, North Carolina, 28601, United States

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Yukon, Oklahoma, 73099, United States

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Downingtown, Pennsylvania, 19335, United States

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King of Prussia, Pennsylvania, 19406, United States

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Morrisville, Pennsylvania, 19067, United States

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Greer, South Carolina, 29651, United States

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Dyersburg, Tennessee, 38024, United States

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Lake Jackson, Texas, 77566, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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Walla Walla, Washington, 99362, United States

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Menomonee Falls, Wisconsin, 53051, United States

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Langley, British Columbia, V3A 4H9, Canada

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Hawkesbury, Ontario, K6A 1A1, Canada

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Kitchener, Ontario, N2C 2N9, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Montreal, Quebec, H3H 1V4, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Ste-foy, Quebec, G1V 4P9, Canada

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Victoriaville, Quebec, G6P 6N2, Canada

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North Battleford, Saskatchewan, S9A 0V6, Canada

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Saskatoon, Saskatchewan, S7K 7H9, Canada

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Providencia, Santiago Metropolitan, Chile

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Bangalore, Karnataka, 560052, India

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Bangalore, Karnataka, 560054, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, 400 012, India

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Nagpur, Maharashtra, India

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Chennai, Tamil Nadu, 600116, India

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Vellore, Tamil Nadu, 632002, India

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Alytus, LT-4580, Lithuania

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Kaunas, LT-3021, Lithuania

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Klaipėda, LT-5800, Lithuania

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Monterrey, Nuevo León, 64460, Mexico

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San Isidro, Lima region, Peru

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San Miguel, Lima region, Peru

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Moscow, 105077, Russia

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Moscow, 105229, Russia

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Moscow, 107066, Russia

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Moscow, 119048, Russia

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Moscow, Russia

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Smolensk, 214019, Russia

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumonia

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 26, 2008
• Study Start: April 1, 2003
• Study Completion: April 1, 2004
• Last Updated: March 26, 2008

Record last verified: 2008-03

Locations

RU (6); US (35); CA (10); PE (2); ME (1); IN (7); LI (3); CL (1)