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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-Acquired Pneumonia (CAP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00035347
Pfizer
Completed
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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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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Community-Acquired Pneumonia (CAP)
  • 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®
  • Drug: IV levofloxacin
    500 mg once daily
    Other Name: Levaquin®
  • Drug: oral levofloxacin
    500 mg once daily
    Other Name: Levaquin®
  • 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
    Interventions:
    • Drug: IV azithromycin
    • Drug: ceftriaxone
    • Drug: oral azithromycin
  • 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.
    Interventions:
    • Drug: IV levofloxacin
    • Drug: oral levofloxacin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
219
June 2002
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Greece,   Spain,   United States
 
 
NCT00035347
A0661035
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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