The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

NCT00809328

Last updated date
Study Location
Pfizer Investigational Site
Seto-shi, Aichi-ken, , Japan
Contact
1-800-718-1021

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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
16-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 16 years of age or older patients with CAP.

- Patients who were diagnosed as moderate in severity.

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


- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides,
or ketolides.


- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).


- Severe renal dysfunction (creatinine clearance < 30 ml/min).


- Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients
who have a congenital or sporadic long QT syndrome, or who are received the drugs with
reported QT prolongation.


- Severe underlying disease.

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Community Acquired Pneumonia (CAP)The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
NCT00809328
  1. Seto-shi, Aichi-ken
  2. Touon, Ehime
  3. Chikushino, Fukuoka
  4. Koga, Fukuoka
  5. Yanagawa, Fukuoka
  6. Higashihiroshima, Hiroshima
  7. Asahikawa, Hokkaido
  8. Himejishi, Hyogo
  9. Moriya-city, Ibaraki
  10. Kanazawa, Ishikawa
  11. Takamatsu, Kagawa
  12. Kawasaki-city, Kanagawa
  13. Tsu, Mie
  14. Sendai, Miyagi
  15. Matsumoto, Nagano
  16. Emukae, Kitamatsuura, Nagasaki
  17. Isahaya, Nagasaki
  18. Nagasaki-city, Nagasaki
  19. Sasebo City, Nagasaki
  20. Niigata-shi, Niigata-ken
  21. Oita City, Oita
  22. Yufu, Oita
  23. Kurashiki, Okayama
  24. Sakai, Osaka
  25. Ureshinoshi, Sagaken
  26. Hamamatsu, Shizuoka
  27. Meguro-Ku, Tokyo
  28. Toshima-ku, Tokyo
  29. Yonezawa, Yamagata
  30. Fukuoka,
  31. Hiroshima,
  32. Kochi,
  33. Okinawa,
  34. Shiogama-city,
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Official Title  ICMJE A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Community Acquired Pneumonia (CAP) Requiring Initial Intravenous Therapy
Brief Summary Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Community Acquired Pneumonia (CAP)
Intervention  ICMJE Drug: Azithromycin
The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
Study Arms  ICMJE Experimental: Azithromycin
Azithromycin switch therapy (switch from intravenous to oral)
Intervention: Drug: Azithromycin
Publications * Kohno S, Tateda K, Kadota J, Fujita J, Niki Y, Watanabe A, Nagashima M. Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia. J Infect Chemother. 2014 Mar;20(3):199-207. doi: 10.1016/j.jiac.2013.10.010. Epub 2013 Dec 11.

*   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: May 5, 2010)
102
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
100
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 16 years of age or older patients with CAP.
  • Patients who were diagnosed as moderate in severity.

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
  • Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
  • Severe renal dysfunction (creatinine clearance < 30 ml/min).
  • Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
  • Severe underlying disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 80 Years   (Child, 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809328
Other Study ID Numbers  ICMJE A0661191
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 May 2011

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