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

Completed · Phase 4

Conditions studied: Community-Acquired Pneumonia (CAP)

In brief

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.

Key facts

Study ID

NCT00035347

Run by

Pfizer

People needed

219

Starts

2001-01-01

Expected to finish

2002-06-01

Last updated by the study team

2017-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Long Beach, California, United States
• Pfizer Investigational Site — Sylmar, California, United States
• Pfizer Investigational Site — Sarasota, Florida, United States
• Pfizer Investigational Site — Columbus, Georgia, United States
• Pfizer Investigational Site — Columbus, Georgia, United States
• Pfizer Investigational Site — Fort Eisenhower, Georgia, United States
• Pfizer Investigational Site — Shawnee Mission, Kansas, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Royal Oak, Michigan, United States
• Pfizer Investigational Site — Kirkwood, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Albuquerque, New Mexico, United States
• Pfizer Investigational Site — Mineola, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Winston-Salem, North Carolina, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Sellersville, Pennsylvania, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Winnipeg, Manitoba, Canada
• Pfizer Investigational Site — Halifax, Nova Scotia, Canada
• Pfizer Investigational Site — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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