Back to resultsThe Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Primary Purpose
Community Acquired Pneumonia (CAP)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Community Acquired Pneumonia (CAP)
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Azithromycin
Arm Description
Azithromycin switch therapy (switch from intravenous to oral)
Outcomes
Primary Outcome Measures
Response Rate (Clinical Response, Data Review Committee Assessment)
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.
Secondary Outcome Measures
Response Rate (Clinical Response, Investigator Assessment)
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)
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)
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00809328
Brief Title
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia (CAP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
Azithromycin switch therapy (switch from intravenous to oral)
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response Rate (Clinical Response, Data Review Committee Assessment)
Description
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.
Time Frame
End of Treatment, Day 15 and Day 29
Secondary Outcome Measure Information:
Title
Response Rate (Clinical Response, Investigator Assessment)
Description
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
Time Frame
End of Treatment, Day 15 and Day 29
Title
The Tendency Toward Clinical Improvement (Investigator Assessment)
Description
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.
Time Frame
Day 3
Title
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Description
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
Time Frame
Day 3, End of Treatment, Day 15 and Day 29
Title
Eradication Rate (Bacteriological Response, Investigator Assessment)
Description
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
Time Frame
Day 3, End of Treatment, Day 15 and Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Seto-shi
State/Province
Aichi-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Touon
State/Province
Ehime
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chikushino
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koga
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yanagawa
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Higashihiroshima
State/Province
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Himejishi
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Moriya-city
State/Province
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawasaki-city
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Pfizer Investigational Site
City
Emukae, Kitamatsuura
State/Province
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Isahaya
State/Province
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagasaki-city
State/Province
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sasebo City
State/Province
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Niigata-shi
State/Province
Niigata-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita City
State/Province
Oita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yufu
State/Province
Oita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ureshinoshi
State/Province
Sagaken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Meguro-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toshima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yonezawa
State/Province
Yamagata
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kochi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okinawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shiogama-city
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24477328
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661191&StudyName=The%20Study%20Of%20Azithromycin%20Switch%20Therapy%20For%20Treatment%20Of%20Community%20Acquired%20Pneumonia%20%28CAP%29
Description
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The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
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