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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Seto-shi, Aichi-ken, Japan
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
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

- 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.

NCT00809328
Pfizer
Completed
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

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The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Community Acquired Pneumonia (CAP)
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.
Experimental: Azithromycin
Azithromycin switch therapy (switch from intravenous to oral)
Intervention: Drug: Azithromycin
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.
 
Completed
102
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 80 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00809328
A0661191
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

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

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