Clinical trial NCT00360295: A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
Official title: A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Community-Acquired
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-04
Enrollment: 153
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: To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000)".

Exclusion Criteria:

* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. ("Severe" assessed by the Severity of underlying diseases and complications of "Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft)" by the Japan Society of Chemotherapy (1997)).

Primary outcomes:
measure: The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.
Secondary outcomes:
measure: Data Review Committee's clinical efficacy (at Day 15 and 29) Investigator's clinical efficacy (at Day 8, 15 and 29), and the tendency toward clinical improvement (at Day 4) Bacteriological efficacy (at Day 4, 8, 15 and 29)
measure: Adverse events and safety Laboratory data
Other outcomes:
Locations:
city: Asahi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Higashi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kasuya-gun
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Munakata
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Nishi-ku
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Isesaki
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Maebashi
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Kamikawa-gun
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Teine
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Hitachinaka
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Hitachi
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Kasama
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Moriya
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Toride
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Marugame
country: Japan
facility: Pfizer Investigational Site
state: Kagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Pfizer Investigational Site
state: Kangawa
city: Emukae, Kitamatsuura
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Hirase-cho, Sasebo,
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Nagasaki-city
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Shigesato-cho, Nagasaki
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Ohte-machi, Oita city
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Oita City, Oita
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Tanaka-machi, Oita
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Yufu
country: Japan
facility: Pfizer Investigational Site
state: Oita
city: Naha
country: Japan
facility: Pfizer Investigational Site
state: Okinawa
city: Nakagami-gun
country: Japan
facility: Pfizer Investigational Site
state: Okinawa
city: Shimajiri-gun
country: Japan
facility: Pfizer Investigational Site
state: Okinawa
city: Daito
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Katano
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kita-ku
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Koshigaya
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kiyose
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Oume,
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Sumida
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: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Okinawa
country: Japan
facility: Pfizer Investigational Site
city: Yamagata
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: