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

NCT00360295 | Completed Phase 3

• 1 other identifier: A0661174
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 54

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.

Conditions

Pneumonia, Community-Acquired

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.

Secondary Outcomes (2)

• 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

Interventions

Azithromycin SR DRUG

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)".

You may not qualify if:

• 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)).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

Pfizer Investigational Site

Asahi, Chiba, 289-2511, Japan

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Pfizer Investigational Site

Fukuoka, Fukuoka, 810-0053, Japan

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Pfizer Investigational Site

Fukuoka, Fukuoka, 813-0031, Japan

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Fukuoka, Fukuoka, 813-0034, Japan

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Higashi, Fukuoka, 812-0053, Japan

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Kasuya-gun, Fukuoka, 811-2122, Japan

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Munakata, Fukuoka, 811-3431, Japan

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Pfizer Investigational Site

Nishiku, Fukuoka, 819-8555, Japan

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Pfizer Investigational Site

Isesaki, Gunma, 372-0817, Japan

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Pfizer Investigational Site

Maebashi, Gunma, 371-0014, Japan

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Pfizer Investigational Site

Asahikawa, Hokkaido, 070-0038, Japan

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Asahikawa, Hokkaido, 070-8012, Japan

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Pfizer Investigational Site

Asahikawa, Hokkaido, 071-8133, Japan

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Asahikawa, Hokkaido, 078-8261, Japan

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Kamikawa-gun, Hokkaido, 071-1521, Japan

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Sapporo, Hokkaido, 004-0022, Japan

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Teine, Hokkaido, 006-0032, Japan

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Hitachi, Ibaraki, 317-0077, Japan

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Hitachi-Naka, Ibaraki, 312-0057, Japan

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Kasama, Ibaraki, 309-1793, Japan

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Moriya, Ibaraki, 302-0118, Japan

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Toride, Ibaraki, 302-0005, Japan

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Tsuchiura, Ibaraki, 300-0053, Japan

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Marugame, Kagawa-ken, 763-0013, Japan

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Yokohama, Kanagawa, 232-0021, Japan

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Pfizer Investigational Site

Yokosuka, Kangawa, 239-0821, Japan

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Emukae, Kitamatsuura, Nagasaki, 859-6131, Japan

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Hirase-cho, Sasebo,, Nagasaki, 857-8511, Japan

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Nagasaki, Nagasaki, 852-8501, Japan

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Shigesato-cho, Nagasaki, Nagasaki, 852-8511, Japan

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Ohte-machi, Oita City, Oita Prefecture, 870-0022, Japan

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Pfizer Investigational Site

Oita City, Oita, Oita Prefecture, 870-0161, Japan

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Pfizer Investigational Site

Ōita, Oita Prefecture, 870-0263, Japan

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Pfizer Investigational Site

Ōita, Oita Prefecture, 870-0921, Japan

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Pfizer Investigational Site

Ōita, Oita Prefecture, 870-8511, Japan

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Pfizer Investigational Site

Tanaka-machi, Oita, Oita Prefecture, 870-0852, Japan

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Yufu, Oita Prefecture, 879-5593, Japan

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Naha, Okinawa, 901-0152, Japan

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Nakagami-gun, Okinawa, 903-0215, Japan

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Okinawa, Okinawa, 904-2195, Japan

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Shimajiri-gun, Okinawa, 901-1303, Japan

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Daitō, Osaka, 574-0014, Japan

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Pfizer Investigational Site

Katano, Osaka, 576-0016, Japan

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Pfizer Investigational Site

Kita-ku, Osaka, 530-0004, Japan

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Pfizer Investigational Site

Koshigaya, Saitama, 343-0807, Japan

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Pfizer Investigational Site

Kiyose, Tokyo, 204-0022, Japan

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Pfizer Investigational Site

Nakano City, Tokyo, 164-0012, Japan

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Pfizer Investigational Site

Ōme, Tokyo, 198-0021, Japan

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Pfizer Investigational Site

Setagaya City, Tokyo, 157-0061, Japan

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Pfizer Investigational Site

Setagaya City, Tokyo, 158-0095, Japan

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Pfizer Investigational Site

Shinagawa, Tokyo, 140-0011, Japan

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Pfizer Investigational Site

Sumida City, Tokyo, 131-0043, Japan

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Pfizer Investigational Site

Yamagata, Yamagata, 990-8545, Japan

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Pfizer Investigational Site

Yonezawa, Yamagata, 992-0045, Japan

Location

Related Links

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

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 4, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

JP (54)