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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00035347
First Posted: May 6, 2002
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Intervention Phase
Community-Acquired Pneumonia (CAP) Drug: IV azithromycin Drug: ceftriaxone Drug: oral azithromycin Drug: IV levofloxacin Drug: oral levofloxacin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 219
Study Start Date: January 2001
Study Completion Date: June 2002
Arms Assigned Interventions
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®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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


  Show 37 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00035347     History of Changes
Other Study ID Numbers: A0661035
First Submitted: May 2, 2002
First Posted: May 6, 2002
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Levofloxacin
Ofloxacin
Ceftriaxone
Azithromycin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial 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