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

Community Acquired Pneumonia (CAP) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809328
• Other study ID #: A0661191
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: May 16, 2011
• Start date: February 2009
• Est. completion date: March 2010

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community Acquired Pneumonia (CAP)
• Pneumonia

Intervention

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.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Asahikawa	Hokkaido
Japan	Pfizer Investigational Site	Chikushino	Fukuoka
Japan	Pfizer Investigational Site	Emukae, Kitamatsuura	Nagasaki
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Hamamatsu	Shizuoka
Japan	Pfizer Investigational Site	Higashihiroshima	Hiroshima
Japan	Pfizer Investigational Site	Himejishi	Hyogo
Japan	Pfizer Investigational Site	Hiroshima
Japan	Pfizer Investigational Site	Isahaya	Nagasaki
Japan	Pfizer Investigational Site	Kanazawa	Ishikawa
Japan	Pfizer Investigational Site	Kawasaki-city	Kanagawa
Japan	Pfizer Investigational Site	Kochi
Japan	Pfizer Investigational Site	Koga	Fukuoka
Japan	Pfizer Investigational Site	Kurashiki	Okayama
Japan	Pfizer Investigational Site	Matsumoto	Nagano
Japan	Pfizer Investigational Site	Meguro-Ku	Tokyo
Japan	Pfizer Investigational Site	Moriya-city	Ibaraki
Japan	Pfizer Investigational Site	Nagasaki-city	Nagasaki
Japan	Pfizer Investigational Site	Niigata-shi	Niigata-ken
Japan	Pfizer Investigational Site	Oita City	Oita
Japan	Pfizer Investigational Site	Okinawa
Japan	Pfizer Investigational Site	Sakai	Osaka
Japan	Pfizer Investigational Site	Sasebo City	Nagasaki
Japan	Pfizer Investigational Site	Sendai	Miyagi
Japan	Pfizer Investigational Site	Seto-shi	Aichi-ken
Japan	Pfizer Investigational Site	Shiogama-city
Japan	Pfizer Investigational Site	Takamatsu	Kagawa
Japan	Pfizer Investigational Site	Toshima-ku	Tokyo
Japan	Pfizer Investigational Site	Touon	Ehime
Japan	Pfizer Investigational Site	Tsu	Mie
Japan	Pfizer Investigational Site	Ureshinoshi	Sagaken
Japan	Pfizer Investigational Site	Yanagawa	Fukuoka
Japan	Pfizer Investigational Site	Yonezawa	Yamagata
Japan	Pfizer Investigational Site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of Treatment, Day 15 and Day 29	No
Secondary	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	End of Treatment, Day 15 and Day 29	No
Secondary	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.	Day 3	No
Secondary	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	Day 3, End of Treatment, Day 15 and Day 29	No
Secondary	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	Day 3, End of Treatment, Day 15 and Day 29	No

External Links

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