Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00035347

Purpose

A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.

Condition	Intervention	Phase
Community-Acquired Pneumonia (CAP)	Drug: IV azithromycin Drug: ceftriaxone Drug: oral azithromycin Drug: IV levofloxacin Drug: oral levofloxacin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicenter, Open Label Trial Comparing Intravenous Zithromax® (Azithromycin) Plus Intravenous Rocephin® (Ceftriaxone) Followed By Oral Zithromax® (Azithromycin) With Intravenous Levaquin® (Levofloxacin) Followed By Oral Levaquin® (Levofloxacin) For The Treatment Of Moderate To Severely Ill Hospitalized Subjects With Community-Acquired Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Ceftriaxone Ceftriaxone Sodium Ofloxacin Azithromycin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Efficacy of sequential therapy with IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® (levofloxacin) followed by oral Levaquin® in the treatment of moderate to severely ill subjects with community-acquired pneumonia. [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and toleration of IV Zithromax® plus IV Rocephin® followed by oral Zithromax® to IV Levaquin® followed by oral Levaquin®, and to compare the bacteriological response rates in subjects with a baseline pathogen. [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Enrollment:	360
Study Start Date:	January 2001
Study Completion Date:	June 2002

Arms	Assigned Interventions
Azithromycin plus ceftriaxone group (AZY+CEF group): Experimental IV azithromycin (500 mg once daily) plus ceftriaxone (1 gram once daily) for 2 to 5 days followed by oral azithromycin (2 x 250 mg once daily) to complete a total of 7 to 10 days of therapy	Drug: IV azithromycin 500 mg once daily Drug: ceftriaxone 1 gram once daily for 2 to 5 days Drug: oral azithromycin 2 x 250 mg once daily
Levofloxacin group (LEV group): Experimental IV levofloxacin (500 mg once daily) for a minimum of 2 days followed by oral levofloxacin (500 mg once daily) to complete a total of 7 to 14 days of therapy.	Drug: IV levofloxacin 500 mg once daily Drug: oral levofloxacin 500 mg once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient must be 18 years or older.
Patient must be hospitalized and require intravenous therapy for treatment of pneumonia.
Patient must have pneumonia as documented by relevant signs and symptoms and a positive chest X-ray.
Patients cannot have certain underlying diseases or conditions as defined in the study protocol.

Exclusion Criteria:

Pregnant women, nursing mothers, or women of childbearing potential not practicing adequate contraception.
Known or suspected hypersensitivity or intolerance to any quinolone, penicillin, cephalosporin, or macrolide antibiotic.
Treatment with any systemic antibiotic for 24 hours or longer within 72 hours prior to the baseline visit.
Subjects with clinically significant renal dysfunction.
Subjects with clinically significant hepatic dysfunction.
Subjects with clinically significant cardiovascular disorders.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035347

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Locations

United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
United States, California
Pfizer Investigational Site
Sylmar, California, United States, 91342
Pfizer Investigational Site
Long Beach, California, United States, 90822
United States, Florida
Pfizer Investigational Site
Sarasota, Florida, United States, 34339
United States, Georgia
Pfizer Investigational Site
Columbus, Georgia, United States, 31902
Pfizer Investigational Site
Ft Gordon, Georgia, United States, 30905
Pfizer Investigational Site
Columbus, Georgia, United States, 31904
United States, Kansas
Pfizer Investigational Site
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40206
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
Pfizer Investigational Site
Royal Oak, Michigan, United States, 48073-6769
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
Kirkwood, Missouri, United States, 63122
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87108-5154
United States, New York
Pfizer Investigational Site
Mineola, New York, United States, 11501
Pfizer Investigational Site
New York, New York, United States, 10003
United States, North Carolina
Pfizer Investigational Site
Winston-salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Columbus, Ohio, United States, 43202
United States, Pennsylvania
Pfizer Investigational Site
Sellersville, Pennsylvania, United States, 18960
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8V 1C3
Pfizer Investigational Site
London, Ontario, Canada, N6A 4G5
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1Y 4E9
Canada, Quebec
Pfizer Investigational Site
Ste-foy, Quebec, Canada, G1V 4G5
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Pfizer Investigational Site
Regina, Saskatchewan, Canada, S4P 1Z7
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7L 2W1
Germany
Pfizer Investigational Site
Luedenscheid, Germany, D58515
Pfizer Investigational Site
Berlin, Germany, D-14109
Germany, Niedersachsen
Pfizer Investigational Site
Rotenburg (wuemme), Niedersachsen, Germany, D-27356
Greece, ATHENS
Pfizer Investigational Site
Maroussi. Attikis, ATHENS, Greece, 15126
Spain, CATALUNA
Pfizer Investigational Site
Barcelona, CATALUNA, Spain, 08036
Pfizer Investigational Site
Tarrasa, CATALUNA, Spain, 08221

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661035
Study First Received:	May 2, 2002
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00035347 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Ceftriaxone
Renal Agents
Pharmacologic Actions

Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Azithromycin
Therapeutic Uses
Pneumonia
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009