Clinical Trial: 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.

This study has been completed.

Sponsored by: Pfizer
Information provided by: Pfizer

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 Treatment or Intervention Phase
Pneumonia
 Drug: IV azithromycin
 Drug: Ceftriaxone
 Drug: Azithromycin tablets
 Drug: IV levofloxacin
 Drug: Levofloxacin tablets
Phase IV

MedlinePlus related topics:  Pneumonia

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

Location Information


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

California
      Pfizer Investigational Site, Sylmar,  California,  91342,  United States

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

Florida
      Pfizer Investigational Site, Sarasota,  Florida,  34239,  United States

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

      Pfizer Investigational Site, Columbus,  Georgia,  31904,  United States

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

Kentucky
      Pfizer Investigational Site, Louisville,  Kentucky,  40202,  United States

Michigan
      Pfizer Investigational Site, Detroit,  Michigan,  48202,  United States

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

Missouri
      Pfizer Investigational Site, Kirkwood,  Missouri,  63122,  United States

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

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

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

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

North Carolina
      Pfizer Investigational Site, Winston Salem,  North Carolina,  27103,  United States

Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44106,  United States

Pennsylvania
      Pfizer Investigational Site, Sellersville,  Pennsylvania,  18960,  United States

      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19140,  United States

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

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

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

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

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

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

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

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

Canada, Saskatchewan
      Pfizer Investigational Site, Regina,  Saskatchewan,  S4P 127,  Canada

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

Germany
      Pfizer Investigational Site, Berlin,  D-14109,  Germany

      Pfizer Investigational Site, LUEDENSCHEID,  58515,  Germany

Germany, Niedersachen
      Pfizer Investigational Site, ROTENBURG,  Niedersachen,  D-27356,  Germany

Greece
      Pfizer Investigational Site, Athens,  15126,  Greece

Spain
      Pfizer Investigational Site, Barcelona,  08036,  Spain

Spain, CATALUNA
      Pfizer Investigational Site, Tarrasa,  CATALUNA,  08221,  Spain

More Information

Study ID Numbers:  A0661035
Record last reviewed:  November 2002
Last Updated:  October 13, 2004
Record first received:  May 2, 2002
ClinicalTrials.gov Identifier:  NCT00035347
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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