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

Sponsored by:	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
Pneumonia, Bacterial	Drug: Azithromycin	Phase III

MedlinePlus related topics: Pneumonia

Drug Information available for: Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

The clinical efficacy assessed by Data Review Committee [ Time Frame: at day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Data Review Committee's clinical efficacy [ Time Frame: at EOT and Day 29 ] [ Designated as safety issue: No ]
Investigator's clinical efficacy [ Time Frame: at EOT, Day 15 and Day 29 ] [ Designated as safety issue: No ]
Data Review Committee's bacteriologic efficacy [ Time Frame: at Day 3, EOT, Day 15 and Day 29 ] [ Designated as safety issue: No ]
Investigator's bacteriologic efficacy [ Time Frame: at Day 3, EOT, Day 15 and Day 29 ] [ Designated as safety issue: No ]
Investigator's the tendency toward clinical improvement [ Time Frame: at Day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Azithromycin: Experimental 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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Japan
Pfizer Investigational Site	Recruiting
Fukuoka, Japan
Pfizer Investigational Site	Recruiting
Kochi, Japan
Pfizer Investigational Site	Recruiting
Okinawa, Japan
Japan, Ehime
Pfizer Investigational Site	Recruiting
Touon, Ehime, Japan
Japan, Fukuoka
Pfizer Investigational Site	Recruiting
Chikushino, Fukuoka, Japan
Japan, Hokkaido
Pfizer Investigational Site	Recruiting
Asahikawa, Hokkaido, Japan
Japan, Hyogo
Pfizer Investigational Site	Recruiting
Himejishi, Hyogo, Japan
Japan, Ibaraki
Pfizer Investigational Site	Recruiting
Moriya-city, Ibaraki, Japan
Japan, Ishikawa
Pfizer Investigational Site	Recruiting
Kanazawa, Ishikawa, Japan
Japan, Miyagi
Pfizer Investigational Site	Recruiting
Sendai, Miyagi, Japan
Japan, Nagano
Pfizer Investigational Site	Recruiting
Matsumoto, Nagano, Japan
Japan, Nagasaki
Pfizer Investigational Site	Recruiting
Nagasaki-city, Nagasaki, Japan
Japan, Oita
Pfizer Investigational Site	Recruiting
Oita City, Oita, Japan
Japan, Osaka
Pfizer Investigational Site	Recruiting
Sakai, Osaka, Japan
Japan, Shizuoka
Pfizer Investigational Site	Recruiting
Hamamatsu, Shizuoka, 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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661191
Study First Received:	December 16, 2008
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00809328 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:

To evaluate the clinical efficacy and safety in patients with community acquired pneumonia receiving azithromycin switch therapy.

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases

Azithromycin
Lung Diseases
Pneumonia, Bacterial
Pneumonia

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses

Azithromycin
Lung Diseases
Pneumonia, Bacterial
Pharmacologic Actions
Pneumonia

ClinicalTrials.gov processed this record on May 07, 2009