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

March 7, 2017 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4G5
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
      • Ste-foy, Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 1Z7
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7L 2W1
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, D-14109
        • Pfizer Investigational Site
      • Luedenscheid, Germany, D58515
        • Pfizer Investigational Site
    • Niedersachsen
      • Rotenburg (wuemme), Niedersachsen, Germany, D-27356
        • Pfizer Investigational Site
  • Greece
    • Athens
      • Maroussi. Attikis, Athens, Greece, 15126
        • Pfizer Investigational Site
  • Spain
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Pfizer Investigational Site
      • Tarrasa, Cataluna, Spain, 08221
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
    • California
      • Long Beach, California, United States, 90822
        • Pfizer Investigational Site
      • Sylmar, California, United States, 91342
        • Pfizer Investigational Site
    • Florida
      • Sarasota, Florida, United States, 34339
        • Pfizer Investigational Site
    • Georgia
      • Columbus, Georgia, United States, 31902
        • Pfizer Investigational Site
      • Columbus, Georgia, United States, 31904
        • Pfizer Investigational Site
      • Ft Gordon, Georgia, United States, 30905
        • Pfizer Investigational Site
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
      • Royal Oak, Michigan, United States, 48073-6769
        • Pfizer Investigational Site
    • Missouri
      • Kirkwood, Missouri, United States, 63122
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5154
        • Pfizer Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • Pfizer Investigational Site
      • New York, New York, United States, 10003
        • Pfizer Investigational Site
    • North Carolina
      • Winston-salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43202
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Pfizer Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Zithromax®
Drug: ceftriaxone
1 gram once daily for 2 to 5 days
Other Names:
  • Rocephin®
Drug: oral azithromycin
2 x 250 mg once daily
Other Names:
  • 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 Names:
  • Levaquin®
Drug: oral levofloxacin
500 mg once daily
Other Names:
  • Levaquin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Duration of trial

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Duration of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 3, 2002

First Posted (Estimate)

May 6, 2002

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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