Pneumonia, Community-Acquired Clinical Trial
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
| Verified date | May 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 80 Years |
| Eligibility |
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)). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Pfizer Investigational Site | Asahi | Chiba |
| Japan | Pfizer Investigational Site | Asahikawa | Hokkaido |
| Japan | Pfizer Investigational Site | Asahikawa | Hokkaido |
| Japan | Pfizer Investigational Site | Asahikawa | Hokkaido |
| Japan | Pfizer Investigational Site | Asahikawa | Hokkaido |
| Japan | Pfizer Investigational Site | Daito | Osaka |
| Japan | Pfizer Investigational Site | Emukae, Kitamatsuura | Nagasaki |
| Japan | Pfizer Investigational Site | Fukuoka | |
| Japan | Pfizer Investigational Site | Fukuoka | |
| Japan | Pfizer Investigational Site | Fukuoka | |
| Japan | Pfizer Investigational Site | Higashi | Fukuoka |
| Japan | Pfizer Investigational Site | Hirase-cho, Sasebo, | Nagasaki |
| Japan | Pfizer Investigational Site | Hitachi | Ibaraki |
| Japan | Pfizer Investigational Site | Hitachinaka | Ibaraki |
| Japan | Pfizer Investigational Site | Isesaki | Gunma |
| Japan | Pfizer Investigational Site | Kamikawa-gun | Hokkaido |
| Japan | Pfizer Investigational Site | Kasama | Ibaraki |
| Japan | Pfizer Investigational Site | Kasuya-gun | Fukuoka |
| Japan | Pfizer Investigational Site | Katano | Osaka |
| Japan | Pfizer Investigational Site | Kita-ku | Osaka |
| Japan | Pfizer Investigational Site | Kiyose | Tokyo |
| Japan | Pfizer Investigational Site | Koshigaya | Saitama |
| Japan | Pfizer Investigational Site | Maebashi | Gunma |
| Japan | Pfizer Investigational Site | Marugame | Kagawa |
| Japan | Pfizer Investigational Site | Moriya | Ibaraki |
| Japan | Pfizer Investigational Site | Munakata | Fukuoka |
| Japan | Pfizer Investigational Site | Nagasaki-city | Nagasaki |
| Japan | Pfizer Investigational Site | Naha | Okinawa |
| Japan | Pfizer Investigational Site | Nakagami-gun | Okinawa |
| Japan | Pfizer Investigational Site | Nakano | Tokyo |
| Japan | Pfizer Investigational Site | Nishi-ku | Fukuoka |
| Japan | Pfizer Investigational Site | Ohte-machi, Oita city | Oita |
| Japan | Pfizer Investigational Site | Oita | |
| Japan | Pfizer Investigational Site | Oita | |
| Japan | Pfizer Investigational Site | Oita | |
| Japan | Pfizer Investigational Site | Oita City, Oita | Oita |
| Japan | Pfizer Investigational Site | Okinawa | |
| Japan | Pfizer Investigational Site | Oume, | Tokyo |
| Japan | Pfizer Investigational Site | Sapporo | Hokkaido |
| Japan | Pfizer Investigational Site | Setagaya | Tokyo |
| Japan | Pfizer Investigational Site | Setagaya | Tokyo |
| Japan | Pfizer Investigational Site | Shigesato-cho, Nagasaki | Nagasaki |
| Japan | Pfizer Investigational Site | Shimajiri-gun | Okinawa |
| Japan | Pfizer Investigational Site | Shinagawa | Tokyo |
| Japan | Pfizer Investigational Site | Sumida | Tokyo |
| Japan | Pfizer Investigational Site | Tanaka-machi, Oita | Oita |
| Japan | Pfizer Investigational Site | Teine | Hokkaido |
| Japan | Pfizer Investigational Site | Toride | Ibaraki |
| Japan | Pfizer Investigational Site | Tsuchiura | Ibaraki |
| Japan | Pfizer Investigational Site | Yamagata | |
| Japan | Pfizer Investigational Site | Yokohama | Kanagawa |
| Japan | Pfizer Investigational Site | Yokosuka | Kangawa |
| Japan | Pfizer Investigational Site | Yonezawa | Yamagata |
| Japan | Pfizer Investigational Site | Yufu | Oita |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint is Data Review Committee's Clinical efficacy at Day 8. | |||
| Secondary | 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) | |||
| Secondary | Adverse events and safety Laboratory data |