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CompletedNCT00360295Updated May 20, 2008

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

A Phase 3 interventional study of Azithromycin SR in Pneumonia, Community-Acquired, sponsored by Pfizer. Completed at 54 sites in Japan. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-05-20.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
153
Allocation
Non-randomized
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumonia, Community-Acquired

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 153 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
153 participants (actual)

Interventions

  • DrugAzithromycin SR
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. 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)

  2. Adverse events and safety Laboratory data

07

Study locations

54 sites
  • Pfizer Investigational Site
    Asahi, Chiba 289-2511, Japan
  • Pfizer Investigational Site
    Higashi, Fukuoka 812-0053, Japan
  • Pfizer Investigational Site
    Kasuya-gun, Fukuoka 811-2122, Japan
  • Pfizer Investigational Site
    Munakata, Fukuoka 811-3431, Japan
  • Pfizer Investigational Site
    Nishi-ku, Fukuoka 819-8555, Japan
  • Pfizer Investigational Site
    Isesaki, Gunma 372-0817, Japan
  • Pfizer Investigational Site
    Maebashi, Gunma 371-0014, Japan
  • Pfizer Investigational Site
    Asahikawa, Hokkaido 070-0038, Japan
  • Pfizer Investigational Site
    Asahikawa, Hokkaido 070-8012, Japan
  • Pfizer Investigational Site
    Asahikawa, Hokkaido 071-8133, Japan
  • Pfizer Investigational Site
    Asahikawa, Hokkaido 078-8261, Japan
  • Pfizer Investigational Site
    Kamikawa-gun, Hokkaido 071-1521, Japan
  • Pfizer Investigational Site
    Sapporo, Hokkaido 004-0022, Japan
  • Pfizer Investigational Site
    Teine, Hokkaido 006-0032, Japan
  • Pfizer Investigational Site
    Hitachinaka, Ibaraki 312-0057, Japan
  • Pfizer Investigational Site
    Hitachi, Ibaraki 317-0077, Japan
  • Pfizer Investigational Site
    Kasama, Ibaraki 309-1793, Japan
  • Pfizer Investigational Site
    Moriya, Ibaraki 302-0118, Japan
  • Pfizer Investigational Site
    Toride, Ibaraki 302-0005, Japan
  • Pfizer Investigational Site
    Tsuchiura, Ibaraki 300-0053, 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
    Hirase-cho, Sasebo,, Nagasaki 857-8511, Japan
  • Pfizer Investigational Site
    Nagasaki-city, Nagasaki 852-8501, Japan
  • Pfizer Investigational Site
    Shigesato-cho, Nagasaki, Nagasaki 852-8511, Japan
  • Pfizer Investigational Site
    Ohte-machi, Oita city, Oita 870-0022, Japan
  • Pfizer Investigational Site
    Oita City, Oita, Oita 870-0161, Japan
  • Pfizer Investigational Site
    Tanaka-machi, Oita, Oita 870-0852, Japan
  • Pfizer Investigational Site
    Yufu, Oita 879-5593, Japan
  • Pfizer Investigational Site
    Naha, Okinawa 901-0152, Japan
  • Pfizer Investigational Site
    Nakagami-gun, Okinawa 903-0215, 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
    Kiyose, Tokyo 204-0022, Japan
  • Pfizer Investigational Site
    Nakano, Tokyo 164-0012, Japan
  • Pfizer Investigational Site
    Oume,, Tokyo 198-0021, Japan
  • Pfizer Investigational Site
    Setagaya, Tokyo 157-0061, Japan
  • Pfizer Investigational Site
    Setagaya, Tokyo 158-0095, Japan
  • Pfizer Investigational Site
    Shinagawa, Tokyo 140-0011, Japan
  • Pfizer Investigational Site
    Sumida, Tokyo 131-0043, Japan
  • Pfizer Investigational Site
    Yonezawa, Yamagata 992-0045, Japan
  • Pfizer Investigational Site
    Fukuoka, 810-0053, Japan
  • Pfizer Investigational Site
    Fukuoka, 813-0031, Japan
  • Pfizer Investigational Site
    Fukuoka, 813-0034, Japan
  • Pfizer Investigational Site
    Oita, 870-0263, Japan
  • Pfizer Investigational Site
    Oita, 870-0921, Japan
  • Pfizer Investigational Site
    Oita, 870-8511, Japan
  • Pfizer Investigational Site
    Okinawa, 904-2195, Japan
  • Pfizer Investigational Site
    Yamagata, 990-8545, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00360295
Lead sponsor
Pfizer
First posted
Aug 4, 2006
Start date
Sep 2006
Primary completion
May 2007
Completion
May 2007
Last update
May 20, 2008

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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