A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults

Condition(s) targeted: Pneumonia

Intervention: Azithromycin SR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

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

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.

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

Primary outcome: The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.

Secondary outcome:

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)

Adverse events and safety Laboratory data

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

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)).

Pfizer Investigational Site, Fukuoka 810-0053, Japan

Pfizer Investigational Site, Fukuoka 813-0034, Japan

Pfizer Investigational Site, Fukuoka 813-0031, Japan

Pfizer Investigational Site, Oita 870-0263, Japan

Pfizer Investigational Site, Oita 870-8511, Japan

Pfizer Investigational Site, Oita 870-0921, Japan

Pfizer Investigational Site, Okinawa 904-2195, Japan

Pfizer Investigational Site, Yamagata 990-8545, Japan

Pfizer Investigational Site, Asahi, Chiba 289-2511, Japan

Pfizer Investigational Site, Nishi-ku, Fukuoka 819-8555, Japan

Pfizer Investigational Site, Kasuya-gun, Fukuoka 811-2122, Japan

Pfizer Investigational Site, Munakata, Fukuoka 811-3431, Japan

Pfizer Investigational Site, Higashi, Fukuoka 812-0053, Japan

Pfizer Investigational Site, Maebashi, Gunma 371-0014, Japan

Pfizer Investigational Site, Isesaki, Gunma 372-0817, Japan

Pfizer Investigational Site, Asahikawa, Hokkaido 070-0038, Japan

Pfizer Investigational Site, Asahikawa, Hokkaido 071-8133, Japan

Pfizer Investigational Site, Asahikawa, Hokkaido 070-8012, Japan

Pfizer Investigational Site, Kamikawa-gun, Hokkaido 071-1521, Japan

Pfizer Investigational Site, Asahikawa, Hokkaido 078-8261, Japan

Pfizer Investigational Site, Teine, Hokkaido 006-0032, Japan

Pfizer Investigational Site, Sapporo, Hokkaido 004-0022, Japan

Pfizer Investigational Site, Hitachinaka, Ibaraki 312-0057, Japan

Pfizer Investigational Site, Tsuchiura, Ibaraki 300-0053, Japan

Pfizer Investigational Site, Toride, Ibaraki 302-0005, Japan

Pfizer Investigational Site, Kasama, Ibaraki 309-1793, Japan

Pfizer Investigational Site, Moriya, Ibaraki 302-0118, Japan

Pfizer Investigational Site, Hitachi, Ibaraki 317-0077, Japan

Pfizer Investigational Site, Marugame, Kagawa 763-0013, Japan

Pfizer Investigational Site, Yokohama, Kanagawa 232-0021, Japan

Pfizer Investigational Site, Yokosuka, Kangawa 239-0821, Japan

Pfizer Investigational Site, Emukae, Kitamatsuura, Nagasaki 859-6131, Japan

Pfizer Investigational Site, Nagasaki-city, Nagasaki 852-8501, Japan

Pfizer Investigational Site, Shigesato-cho, Nagasaki, Nagasaki 852-8511, Japan

Pfizer Investigational Site, Hirase-cho, Sasebo,, Nagasaki 857-8511, Japan

Pfizer Investigational Site, Yufu, Oita 879-5593, Japan

Pfizer Investigational Site, Tanaka-machi, Oita, Oita 870-0852, Japan

Pfizer Investigational Site, Oita City, Oita, Oita 870-0161, Japan

Pfizer Investigational Site, Ohte-machi, Oita city, Oita 870-0022, Japan

Pfizer Investigational Site, Nakagami-gun, Okinawa 903-0215, Japan

Pfizer Investigational Site, Naha, Okinawa 901-0152, Japan

Pfizer Investigational Site, Shimajiri-gun, Okinawa 901-1303, Japan

Pfizer Investigational Site, Daito, Osaka 574-0014, Japan

Pfizer Investigational Site, Katano, Osaka 576-0016, Japan

Pfizer Investigational Site, Kita-ku, Osaka 530-0004, Japan

Pfizer Investigational Site, Koshigaya, Saitama 343-0807, Japan

Pfizer Investigational Site, Shinagawa, Tokyo 140-0011, Japan

Pfizer Investigational Site, Sumida, Tokyo 131-0043, Japan

Pfizer Investigational Site, Setagaya, Tokyo 157-0061, Japan

Pfizer Investigational Site, Setagaya, Tokyo 158-0095, Japan

Pfizer Investigational Site, Nakano, Tokyo 164-0012, Japan

Pfizer Investigational Site, Kiyose, Tokyo 204-0022, Japan

Pfizer Investigational Site, Oume,, Tokyo 198-0021, Japan

Pfizer Investigational Site, Yonezawa, Yamagata 992-0045, Japan

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

Starting date: September 2006
Ending date: May 2007
Last updated: July 2, 2007