Infections, NosocomialPhase 3NCT00150332
Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan
A Phase 3 study testing linezolid in people with Infections, Nosocomial, run by Pfizer at 20 sites in Japan.
Trial summary
Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Infections, Nosocomial
- What is being tested?
- linezolid
- How many people
- 24 participants
- Where
- 20 sitesJapan
- Study dates
- Jan 2003to Jan 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- infection due to methicillin-resistant Staphylococcus aureus
Who cannot join
- hypersensitivity to linezolid
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Pfizer Investigational Site
Fukuoka, Fukuoka, 811-0213
Pfizer Investigational Site
Fukuoka, Fukuoka, 813-0025
Pfizer Investigational Site
Hiroshima, Hiroshima, 730-8619
Pfizer Investigational Site
Hiroshima, Hiroshima, 734-8530
Pfizer Investigational Site
Iruma-gun, Saitama, 350-0495
Pfizer Investigational Site
Isahaya, Nagasaki, 854-8501
Pfizer Investigational Site
Kamogawa, Chiba, 296-0041
Pfizer Investigational Site
Kodaira, Tokyo, 187-0004
Pfizer Investigational Site
Kurashiki, Okayama-ken, 701-0912
Pfizer Investigational Site
Kurashiki, Okayama-ken
Pfizer Investigational Site
Kyoto, Kyoto, 615-8256
Pfizer Investigational Site
Moriya, Ibaraki, 302-0118
Pfizer Investigational Site
Nagasaki, Nagasaki, 852-8501
Pfizer Investigational Site
Okayama, Okayama-ken, 700-8505
Pfizer Investigational Site
Okayama, Okayama-ken, 703-8275
Pfizer Investigational Site
Onga-gun, Fukuoka, 807-0051
Pfizer Investigational Site
Sappopro, Hokkaido, 060-8648
Pfizer Investigational Site
Sapporo, Hokkaido, 006-8555
Pfizer Investigational Site
Suita, Osaka, 565-8565
Pfizer Investigational Site
Yokohama, Kanagawa, 236-0051
About this study
Official title: Linezolid (PNU-10766/PNU10766SS) in the Treatment of MRSA Infections in Patients Whose Conventional Therapy Has Failed, or Who Are Intolerant to Conventional Therapy; an Open-label, Multi-center Trial
Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan
- Conditions
- Infections, Nosocomial
- Being tested
- linezolid
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linezolidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of infection at the time of completion of therapy
Secondary outcomes (1)
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, NosocomialStudies 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
- 24 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
- NCT00150332
- Sponsor's protocol ID
- M12600067
- Other IDs
- A5951054
- Status last verified
- May 2011
- First submitted
- 6 Sep 2005
- Last updated
- 10 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linezolid (PNU-10766/PNU10766SS) in the Treatment of MRSA Infections in Patients Whose Conventional Therapy Has Failed, or Who Are Intolerant to Conventional Therapy; an Open-label, Multi-center Trial
- ClinicalTrials.gov ID
- NCT00150332
- Acronym / sponsor ID
- M12600067
- Conditions
- Infections, Nosocomial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 8 Sep 2005 (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.
Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- infection due to methicillin-resistant Staphylococcus aureus
Key exclusion criteria (1 listed)
- hypersensitivity to linezolid
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 |
|---|---|---|
| linezolid | Drug | – |
Primary outcome
Resolution of infection at the time of completion of therapy
1 secondary outcome
Adverse events
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 10 May 2011.
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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
20 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 linezolid in people with Infections, Nosocomial, run by Pfizer at 20 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 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
Resolution of infection at the time of completion of therapy. 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 10 May 2011.