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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NCT00035347

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
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Contact
1-800-718-1021
[email protected]
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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.

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Community-Acquired Pneumonia (CAP)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 NCT00035347
  1. Birmingham, Alabama
  2. Long Beach, California
  3. Sylmar, California
  4. Sarasota, Florida
  5. Columbus, Georgia
  6. Columbus, Georgia
  7. Ft Gordon, Georgia
  8. Shawnee Mission, Kansas
  9. Louisville, Kentucky
  10. Detroit, Michigan
  11. Royal Oak, Michigan
  12. Kirkwood, Missouri
  13. St. Louis, Missouri
  14. Albuquerque, New Mexico
  15. Mineola, New York
  16. New York, New York
  17. Winston-salem, North Carolina
  18. Cleveland, Ohio
  19. Columbus, Ohio
  20. Philadelphia, Pennsylvania
  21. Sellersville, Pennsylvania
  22. San Antonio, Texas
  23. Winnipeg, Manitoba
  24. Halifax, Nova Scotia
  25. Hamilton, Ontario
  26. London, Ontario
  27. Ottawa, Ontario
  28. Montreal, Quebec
  29. Ste-foy, Quebec
  30. Regina, Saskatchewan
  31. Saskatoon, Saskatchewan
  32. Rotenburg (wuemme), Niedersachsen
  33. Berlin,
  34. Luedenscheid,
  35. Maroussi. Attikis, Athens
  36. Barcelona, Cataluna
  37. Tarrasa, Cataluna
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Community-Acquired Pneumonia (CAP)
Intervention  ICMJE
  • 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®
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2011)		219
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		360
Actual Study Completion Date  ICMJE June 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Greece,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00035347
Other Study ID Numbers  ICMJE A0661035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP