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Trial record 1 of 1 for:    A0661191
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The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

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ClinicalTrials.gov Identifier: NCT00809328
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : April 13, 2011
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 16, 2008
First Posted Date  ICMJE December 17, 2008
Results First Submitted Date  ICMJE March 22, 2011
Results First Posted Date  ICMJE April 13, 2011
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
Response Rate (Clinical Response, Data Review Committee Assessment) [ Time Frame: End of Treatment, Day 15 and Day 29 ]
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
The clinical efficacy assessed by Data Review Committee [ Time Frame: at day 15 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2011)
  • Response Rate (Clinical Response, Investigator Assessment) [ Time Frame: End of Treatment, Day 15 and Day 29 ]
    Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100
  • The Tendency Toward Clinical Improvement (Investigator Assessment) [ Time Frame: Day 3 ]
    The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 3, and was determined to continue the treatment.
  • Eradication Rate (Bacteriological Response, Data Review Committee Assessment) [ Time Frame: Day 3, End of Treatment, Day 15 and Day 29 ]
    Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
  • Eradication Rate (Bacteriological Response, Investigator Assessment) [ Time Frame: Day 3, End of Treatment, Day 15 and Day 29 ]
    Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
  • Data Review Committee's clinical efficacy [ Time Frame: at EOT and Day 29 ]
  • Investigator's clinical efficacy [ Time Frame: at EOT, Day 15 and Day 29 ]
  • Data Review Committee's bacteriologic efficacy [ Time Frame: at Day 3, EOT, Day 15 and Day 29 ]
  • Investigator's bacteriologic efficacy [ Time Frame: at Day 3, EOT, Day 15 and Day 29 ]
  • Investigator's the tendency toward clinical improvement [ Time Frame: at Day 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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