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.

Condition(s) targeted: Pneumonia

Intervention: IV azithromycin (Drug); Ceftriaxone (Drug); Azithromycin tablets (Drug); IV levofloxacin (Drug); Levofloxacin tablets (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

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.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Pfizer Investigational Site, Berlin D-14109, Germany

Pfizer Investigational Site, Luedenscheid 58515, Germany

Pfizer Investigational Site, Athens 15126, Greece

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Phenix City, Alabama 36867, United States

Pfizer Investigational Site, Tarrasa, CATALUNA 08221, Spain

Pfizer Investigational Site, Sylmar, California 91342, United States

Pfizer Investigational Site, Long Beach, California 90822, United States

Pfizer Investigational Site, Sarasota, Florida 34239, United States

Pfizer Investigational Site, Ft. Gordon, Georgia 30905, United States

Pfizer Investigational Site, Columbus, Georgia 31904, United States

Pfizer Investigational Site, Shawnee Mission, Kansas 66204, United States

Pfizer Investigational Site, Louisville, Kentucky 40202, United States

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1R9, Canada

Pfizer Investigational Site, Detroit, Michigan 48202, United States

Pfizer Investigational Site, Royal Oak, Michigan 48073, United States

Pfizer Investigational Site, Kirkwood, Missouri 63122, United States

Pfizer Investigational Site, Saint Louis, Missouri 63110, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87108, United States

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Pfizer Investigational Site, Mineola, New York 11501, United States

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Pfizer Investigational Site, Halifax, Nova Scotia B3H 3A7, Canada

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

Pfizer Investigational Site, Hamilton, Ontario L8V 1C3, Canada

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Pfizer Investigational Site, Sellersville, Pennsylvania 18960, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States

Pfizer Investigational Site, Saint-Nicolas, Quebec G7A 2S2, Canada

Pfizer Investigational Site, Montreal, Quebec H1T 2M4, Canada

Pfizer Investigational Site, Regina, Saskatchewan S4P 127, Canada

Pfizer Investigational Site, Saskatoon, Saskatchewan S7L 2W1, Canada

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Last updated: June 23, 2005