Clinical trial NCT00809328: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community Acquired Pneumonia (CAP)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 102
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Response Rate (Clinical Response, Data Review Committee Assessment)
timeFrame: End of Treatment, Day 15 and Day 29
Secondary outcomes:
measure: Response Rate (Clinical Response, Investigator Assessment)
timeFrame: End of Treatment, Day 15 and Day 29
measure: The Tendency Toward Clinical Improvement (Investigator Assessment)
timeFrame: Day 3
measure: Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
timeFrame: Day 3, End of Treatment, Day 15 and Day 29
measure: Eradication Rate (Bacteriological Response, Investigator Assessment)
timeFrame: Day 3, End of Treatment, Day 15 and Day 29
Other outcomes:
Locations:
city: Seto-shi
country: Japan
facility: Pfizer Investigational Site
state: Aichi-ken
city: Touon
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Chikushino
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Koga
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Yanagawa
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Higashihiroshima
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Himejishi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Moriya-city
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Pfizer Investigational Site
state: Ishikawa
city: Takamatsu
country: Japan
facility: Pfizer Investigational Site
state: Kagawa
city: Kawasaki-city
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Tsu
country: Japan
facility: Pfizer Investigational Site
state: Mie
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Matsumoto
country: Japan
facility: Pfizer Investigational Site
state: Nagano
city: Emukae, Kitamatsuura
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Isahaya
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Nagasaki-city
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Sasebo City
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Niigata-shi
country: Japan
facility: Pfizer Investigational Site
state: Niigata-ken
city: Oita City
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Yufu
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Kurashiki
country: Japan
facility: Pfizer Investigational Site
state: Okayama
city: Sakai
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Ureshinoshi
country: Japan
facility: Pfizer Investigational Site
state: Sagaken
city: Hamamatsu
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Meguro-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Yonezawa
country: Japan
facility: Pfizer Investigational Site
state: Yamagata
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kochi
country: Japan
facility: Pfizer Investigational Site
city: Okinawa
country: Japan
facility: Pfizer Investigational Site
city: Shiogama-city
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.