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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

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ClinicalTrials.gov Identifier: NCT00035347
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : March 10, 2017
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Community-Acquired Pneumonia (CAP) Drug: IV azithromycin Drug: ceftriaxone Drug: oral azithromycin Drug: IV levofloxacin Drug: oral levofloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2001
Actual Study Completion Date : June 2002


Arm Intervention/treatment
Experimental: Azithromycin plus ceftriaxone group (AZY+CEF group)
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
Other Name: Zithromax®

Drug: ceftriaxone
1 gram once daily for 2 to 5 days
Other Name: Rocephin®

Drug: oral azithromycin
2 x 250 mg once daily
Other Name: Zithromax®

Experimental: Levofloxacin group (LEV group)
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
Other Name: Levaquin®

Drug: oral levofloxacin
500 mg once daily
Other Name: Levaquin®




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035347


Locations
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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
United States, California
Pfizer Investigational Site
Long Beach, California, United States, 90822
Pfizer Investigational Site
Sylmar, California, United States, 91342
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
Columbus, Georgia, United States, 31904
Pfizer Investigational Site
Ft Gordon, Georgia, United States, 30905
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
Kirkwood, Missouri, United States, 63122
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
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
Philadelphia, Pennsylvania, United States, 19140
Pfizer Investigational Site
Sellersville, Pennsylvania, United States, 18960
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
Montreal, Quebec, Canada, H1T 2M4
Pfizer Investigational Site
Ste-foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Pfizer Investigational Site
Regina, Saskatchewan, Canada, S4P 1Z7
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7L 2W1
Germany
Pfizer Investigational Site
Rotenburg (wuemme), Niedersachsen, Germany, D-27356
Pfizer Investigational Site
Berlin, Germany, D-14109
Pfizer Investigational Site
Luedenscheid, Germany, D58515
Greece
Pfizer Investigational Site
Maroussi. Attikis, Athens, Greece, 15126
Spain
Pfizer Investigational Site
Barcelona, Cataluna, Spain, 08036
Pfizer Investigational Site
Tarrasa, Cataluna, Spain, 08221
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00035347    
Other Study ID Numbers: A0661035
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin
Levofloxacin
Ofloxacin
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors