A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

NCT00643227 | Completed Phase 3

• 1 other identifier: A0661075
• Study Type: interventional
• Target: 504
• Locations: 7 countries
• Sites: 71

Brief Summary

The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (10)

• bacteriologic response (eradication rate) in the Bacteriological Per Protocol population

  TOC visit

• investigator assessment of clinical response in the Clinical Per Protocol population

  TOC visit

• sponsor assessment of clinical response by baseline pathogen

  End of Treatment (EOT) visit (Day 8-11) and TOC visit

• sponsor assessment of clinical response in the non-primary population

  EOT visit and TOC visit

• sponsor assessment of clinical responses in the Clinical Per Protocol population

  EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)

Study Arms (2)

1

EXPERIMENTAL

Drug: clarithromycin extended release (ER)

2

EXPERIMENTAL

Drug: azithromycin SR

Interventions

clarithromycin extended release (ER) DRUG

7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily

1

azithromycin SR DRUG

Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC \>10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).

You may not qualify if:

• Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (72)

Pfizer Investigational Site

Birmingham, Alabama, 35215, United States

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Birmingham, Alabama, 35242, United States

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Haleyville, Alabama, 35565, United States

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Montgomery, Alabama, 36106, United States

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Montgomery, Alabama, 36109, United States

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Tallassee, Alabama, 36078, United States

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Mesa, Arizona, 85201, United States

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Phoenix, Arizona, 85014, United States

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Tempe, Arizona, 85282, United States

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La Jolla, California, 92037, United States

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San Diego, California, 92128, United States

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Orlando, Florida, 32806, United States

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Boise, Idaho, 83703, United States

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Boise, Idaho, 83704, United States

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Boise, Idaho, 83706, United States

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Boise, Idaho, 83709, United States

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Boise, Idaho, 83713, United States

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Meridian, Idaho, 83642, United States

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Nampa, Idaho, 83651, United States

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Chalmette, Louisiana, 70043, United States

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New Orleans, Louisiana, 70112, United States

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New Orleans, Louisiana, 70128, United States

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Butte, Montana, 59701, United States

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Holmdel, New Jersey, 07733, United States

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Clemmons, North Carolina, 27012, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Charleston, South Carolina, 29406, United States

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Summerville, South Carolina, 29485, United States

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Milan, Tennessee, 38358, United States

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Salt Lake City, Utah, 84102, 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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Taylorsville, Utah, 84118, United States

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West Jordan, Utah, 84088, United States

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Casper, Wyoming, 82601, United States

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Tandil, Buenos Aires, B7000AXD, Argentina

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Buenos Aires, 1427, Argentina

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Buenos Aires, C1120AAF, Argentina

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Buenos Aires, C1272AAA, Argentina

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Buenos Aires, C1282AFQ, Argentina

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Edmonton, Alberta, T5A 4L8, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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St. John's, Newfoundland and Labrador, A1E 2E2, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Drummondville, Quebec, J2B 1H8, Canada

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Granby, Quebec, J2G 8Z9, Canada

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Longueuil, Quebec, J4N 1E1, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

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Ste-Foy, Quebec, G1V 4G5, Canada

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Saskatoon, Saskatchewan, S7K 3H3, Canada

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Tallinn, 10617, Estonia

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Tallinn, 13419, Estonia

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Tallinn, 13619, Estonia

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Tartu, 51014, Estonia

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Hyderabad, Andhra Pradesh, 500 033, India

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Bangalore, Karnataka, 560 034, India

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Elamakkara, Cochin, Kerala, 682 026, India

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Pune, Maharashtra, 411 053, India

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Ludhiana, Punjab, 141 001, India

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Coimbatore, Tamil Nadu, 641 022, India

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Kaunas, LT-3000, Lithuania

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Vilnius, LT-2010, Lithuania

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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

Condition Hierarchy (Ancestors)

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

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: January 1, 2003
• Study Completion: March 1, 2004
• Last Updated: March 26, 2008

Record last verified: 2008-03

Locations

US (36); ES (4); IN (6); CA (12); LI (2); RU (6); AR (5)