The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP) - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00809328

Purpose

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.

Condition	Intervention	Phase
Community Acquired Pneumonia (CAP)	Drug: Azithromycin	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Response Rate (Clinical Response, Data Review Committee Assessment) [ Time Frame: End of Treatment, Day 15 and Day 29 ] [ Designated as safety issue: No ]
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) [ Time Frame: End of Treatment, Day 15 and Day 29 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Enrollment:	102
Study Start Date:	February 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Azithromycin Azithromycin switch therapy (switch from intravenous to oral)	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.

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809328

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00809328 History of Changes
Other Study ID Numbers:	A0661191
Study First Received:	December 16, 2008
Results First Received:	March 22, 2011
Last Updated:	May 16, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012