Pneumonia, Community-AcquiredPhase 3NCT00360295
A Trial Of Azithromycin SR For The Treatment Of Mild To Moderate Community Acquired Pneumonia In Japanese Adults
A Phase 3 study testing Azithromycin SR in people with Pneumonia, Community-Acquired, run by Pfizer at 54 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Pneumonia, Community-Acquired
- What is being tested?
- Azithromycin SR
- How many people
- 153 participants
- Where
- 54 sitesJapan
- Study dates
- Sep 2006to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)".
Who cannot join
- 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)).
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Japan54 sites
Pfizer Investigational Site
Asahi, Chiba, 289-2511
Pfizer Investigational Site
Asahikawa, Hokkaido, 070-0038
Pfizer Investigational Site
Asahikawa, Hokkaido, 070-8012
Pfizer Investigational Site
Asahikawa, Hokkaido, 071-8133
Pfizer Investigational Site
Asahikawa, Hokkaido, 078-8261
Pfizer Investigational Site
Daitō, Osaka, 574-0014
Pfizer Investigational Site
Emukae, Kitamatsuura, Nagasaki, 859-6131
Pfizer Investigational Site
Fukuoka, Fukuoka, 810-0053
Pfizer Investigational Site
Fukuoka, Fukuoka, 813-0031
Pfizer Investigational Site
Fukuoka, Fukuoka, 813-0034
Pfizer Investigational Site
Higashi, Fukuoka, 812-0053
Pfizer Investigational Site
Hirase-cho, Sasebo,, Nagasaki, 857-8511
Pfizer Investigational Site
Hitachi, Ibaraki, 317-0077
Pfizer Investigational Site
Hitachi-Naka, Ibaraki, 312-0057
Pfizer Investigational Site
Isesaki, Gunma, 372-0817
Pfizer Investigational Site
Kamikawa-gun, Hokkaido, 071-1521
Pfizer Investigational Site
Kasama, Ibaraki, 309-1793
Pfizer Investigational Site
Kasuya-gun, Fukuoka, 811-2122
Pfizer Investigational Site
Katano, Osaka, 576-0016
Pfizer Investigational Site
Kita-ku, Osaka, 530-0004
Pfizer Investigational Site
Kiyose, Tokyo, 204-0022
Pfizer Investigational Site
Koshigaya, Saitama, 343-0807
Pfizer Investigational Site
Maebashi, Gunma, 371-0014
Pfizer Investigational Site
Marugame, Kagawa-ken, 763-0013
Pfizer Investigational Site
Moriya, Ibaraki, 302-0118
Pfizer Investigational Site
Munakata, Fukuoka, 811-3431
Pfizer Investigational Site
Nagasaki, Nagasaki, 852-8501
Pfizer Investigational Site
Naha, Okinawa, 901-0152
Pfizer Investigational Site
Nakagami-gun, Okinawa, 903-0215
Pfizer Investigational Site
Nakano City, Tokyo, 164-0012
Pfizer Investigational Site
Nishiku, Fukuoka, 819-8555
Pfizer Investigational Site
Ohte-machi, Oita City, Oita Prefecture, 870-0022
Pfizer Investigational Site
Ōita, Oita Prefecture, 870-0263
Pfizer Investigational Site
Ōita, Oita Prefecture, 870-0921
Pfizer Investigational Site
Ōita, Oita Prefecture, 870-8511
Pfizer Investigational Site
Oita City, Oita, Oita Prefecture, 870-0161
Pfizer Investigational Site
Okinawa, Okinawa, 904-2195
Pfizer Investigational Site
Ōme, Tokyo, 198-0021
Pfizer Investigational Site
Sapporo, Hokkaido, 004-0022
Pfizer Investigational Site
Setagaya City, Tokyo, 157-0061
Pfizer Investigational Site
Setagaya City, Tokyo, 158-0095
Pfizer Investigational Site
Shigesato-cho, Nagasaki, Nagasaki, 852-8511
Pfizer Investigational Site
Shimajiri-gun, Okinawa, 901-1303
Pfizer Investigational Site
Shinagawa, Tokyo, 140-0011
Pfizer Investigational Site
Sumida City, Tokyo, 131-0043
Pfizer Investigational Site
Tanaka-machi, Oita, Oita Prefecture, 870-0852
Pfizer Investigational Site
Teine, Hokkaido, 006-0032
Pfizer Investigational Site
Toride, Ibaraki, 302-0005
Pfizer Investigational Site
Tsuchiura, Ibaraki, 300-0053
Pfizer Investigational Site
Yamagata, Yamagata, 990-8545
Pfizer Investigational Site
Yokohama, Kanagawa, 232-0021
Pfizer Investigational Site
Yokosuka, Kangawa, 239-0821
Pfizer Investigational Site
Yonezawa, Yamagata, 992-0045
Pfizer Investigational Site
Yufu, Oita Prefecture, 879-5593
About this study
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
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
- Being tested
- Azithromycin SR
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin SRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Community-AcquiredStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360295
- Sponsor's protocol ID
- A0661174
- Status last verified
- May 2008
- First submitted
- 3 Aug 2006
- Last updated
- 20 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00360295
- Acronym / sponsor ID
- A0661174
- Conditions
- Pneumonia, Community-Acquired
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 4 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)".
Key exclusion criteria (1 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin SR | Drug | – |
Primary outcome
The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Local Antibiotic Delivery for Community Acquired Pneumonia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin SR in people with Pneumonia, Community-Acquired, run by Pfizer at 54 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is Data Review Committee's Clinical efficacy at Day 8.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2008.