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: Community-Acquired Pneumonia (CAP)

Intervention: IV azithromycin (Drug); ceftriaxone (Drug); oral azithromycin (Drug); IV levofloxacin (Drug); oral levofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: 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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

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

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.

Pfizer Investigational Site, Berlin D-14109, Germany

Pfizer Investigational Site, Luedenscheid D58515, Germany

Pfizer Investigational Site, Birmingham, Alabama 35233, United States

Pfizer Investigational Site, Maroussi. Attikis, Athens 15126, Greece

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

Pfizer Investigational Site, Sylmar, California 91342, United States

Pfizer Investigational Site, Barcelona, Cataluna 08036, Spain

Pfizer Investigational Site, Tarrasa, Cataluna 08221, Spain

Pfizer Investigational Site, Sarasota, Florida 34339, United States

Pfizer Investigational Site, Columbus, Georgia 31902, United States

Pfizer Investigational Site, Columbus, Georgia 31904, United States

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

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

Pfizer Investigational Site, Louisville, Kentucky 40206, United States

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

Pfizer Investigational Site, Detroit, Michigan 48202, United States

Pfizer Investigational Site, Royal Oak, Michigan 48073-6769, United States

Pfizer Investigational Site, Kirkwood, Missouri 63122, United States

Pfizer Investigational Site, St. Louis, Missouri 63110, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87108-5154, United States

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

Pfizer Investigational Site, New York, New York 10003, United States

Pfizer Investigational Site, Rotenburg (wuemme), Niedersachsen D-27356, Germany

Pfizer Investigational Site, Winston-salem, North Carolina 27103, United States

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

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

Pfizer Investigational Site, Columbus, Ohio 43202, United States

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

Pfizer Investigational Site, London, Ontario N6A 4G5, Canada

Pfizer Investigational Site, Ottawa, Ontario K1Y 4E9, Canada

Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States

Pfizer Investigational Site, Sellersville, Pennsylvania 18960, United States

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

Pfizer Investigational Site, Ste-foy, Quebec G1V 4G5, Canada

Pfizer Investigational Site, Regina, Saskatchewan S4P 1Z7, Canada

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

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

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

Starting date: January 2001
Last updated: April 25, 2011