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

Condition(s) targeted: Pneumonia, Bacterial

Intervention: Azithromycin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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 design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The clinical efficacy assessed by Data Review Committee

Secondary outcome:

Data Review Committee's clinical efficacy

Investigator's clinical efficacy

Data Review Committee's bacteriologic efficacy

Investigator's bacteriologic efficacy

Investigator's the tendency toward clinical improvement

Minimum age: 16 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Shiogama-city, Japan; Recruiting

Pfizer Investigational Site, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Kochi, Japan; Recruiting

Pfizer Investigational Site, Okinawa, Japan; Recruiting

Pfizer Investigational Site, Seto-shi, AICHI-KEN, Japan; Recruiting

Pfizer Investigational Site, Touon, Ehime, Japan; Recruiting

Pfizer Investigational Site, Koga, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Chikushino, Fukuoka, Japan; Recruiting

Pfizer Investigational Site, Asahikawa, Hokkaido, Japan; Recruiting

Pfizer Investigational Site, Himejishi, Hyogo, Japan; Recruiting

Pfizer Investigational Site, Moriya-city, Ibaraki, Japan; Recruiting

Pfizer Investigational Site, Kanazawa, Ishikawa, Japan; Recruiting

Pfizer Investigational Site, Sendai, Miyagi, Japan; Recruiting

Pfizer Investigational Site, Matsumoto, Nagano, Japan; Recruiting

Pfizer Investigational Site, Nagasaki-city, Nagasaki, Japan; Recruiting

Pfizer Investigational Site, Sasebo City, Nagasaki, Japan; Recruiting

Pfizer Investigational Site, Isahaya, Nagasaki, Japan; Recruiting

Pfizer Investigational Site, Yufu, Oita, Japan; Recruiting

Pfizer Investigational Site, Oita City, Oita, Japan; Recruiting

Pfizer Investigational Site, Sakai, Osaka, Japan; Recruiting

Pfizer Investigational Site, Ureshinoshi, Sagaken, Japan; Recruiting

Pfizer Investigational Site, Hamamatsu, Shizuoka, Japan; Recruiting

Pfizer Investigational Site, Toshima-ku, Tokyo, Japan; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: February 2009
Ending date: February 2010
Last updated: October 2, 2009