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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

Primary Purpose

Community-Acquired Pneumonia (CAP)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
IV azithromycin
ceftriaxone
oral azithromycin
IV levofloxacin
oral levofloxacin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-Acquired Pneumonia (CAP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Azithromycin plus ceftriaxone group (AZY+CEF group)

Levofloxacin group (LEV group)

Arm Description

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

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.

Outcomes

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.

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.

Full Information

First Posted
May 2, 2002
Last Updated
March 7, 2017
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00035347
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-Acquired Pneumonia (CAP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin plus ceftriaxone group (AZY+CEF group)
Arm Type
Experimental
Arm Description
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
Arm Title
Levofloxacin group (LEV group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV azithromycin
Other Intervention Name(s)
Zithromax®
Intervention Description
500 mg once daily
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Other Intervention Name(s)
Rocephin®
Intervention Description
1 gram once daily for 2 to 5 days
Intervention Type
Drug
Intervention Name(s)
oral azithromycin
Other Intervention Name(s)
Zithromax®
Intervention Description
2 x 250 mg once daily
Intervention Type
Drug
Intervention Name(s)
IV levofloxacin
Other Intervention Name(s)
Levaquin®
Intervention Description
500 mg once daily
Intervention Type
Drug
Intervention Name(s)
oral levofloxacin
Other Intervention Name(s)
Levaquin®
Intervention Description
500 mg once daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Pfizer Investigational Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Pfizer Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34339
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31902
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Pfizer Investigational Site
City
Ft Gordon
State/Province
Georgia
ZIP/Postal Code
30905
Country
United States
Facility Name
Pfizer Investigational Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Pfizer Investigational Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
Pfizer Investigational Site
City
Kirkwood
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5154
Country
United States
Facility Name
Pfizer Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Pfizer Investigational Site
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 1Z7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7L 2W1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Rotenburg (wuemme)
State/Province
Niedersachsen
ZIP/Postal Code
D-27356
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
D-14109
Country
Germany
Facility Name
Pfizer Investigational Site
City
Luedenscheid
ZIP/Postal Code
D58515
Country
Germany
Facility Name
Pfizer Investigational Site
City
Maroussi. Attikis
State/Province
Athens
ZIP/Postal Code
15126
Country
Greece
Facility Name
Pfizer Investigational Site
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Tarrasa
State/Province
Cataluna
ZIP/Postal Code
08221
Country
Spain

12. IPD Sharing Statement

Learn more about this 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

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