Bacterial InfectionsPhase 3NCT00037050
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
A Phase 3 study testing Linezolid, Vancomycin and Oxacillin in people with Bacterial Infections and Gram-Positive Bacterial Infections, run by Pfizer.
Trial summary
This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria) Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Bacterial Infections, Gram-Positive Bacterial Infections, Bacteremia
- What is being tested?
- Linezolid, Vancomycin and Oxacillin
- How many people
- 739 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Jul 2005
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a central indwelling catheter with signs and symptoms of infection
Who cannot join
- Patients with tunneled catheter which cannot be removed.
- Patients with evidence of endovascular infection including endocarditis.
- Patients with infection of permanent intravascular devices.
- Patients who have received more than 1 day of another antibiotic before enrollment.
- Patients with HIV and low CD4 count.
About this study
Official title: Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections
This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)
- Being tested
- Linezolid, Vancomycin, Oxacillin, Dicloxacillin
- Medical subject headings
- Bacterial Infections, Gram-Positive Bacterial Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
Also called Zyvox
VancomycinDrug
OxacillinDrug
DicloxacillinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
The empiric treatment of patients with gram-positive catheter-related bloodstream infections.
Secondary outcomes (1)
Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2002 (estimated)
- Study startApr 2002
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 739 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
- NCT00037050
- Sponsor's protocol ID
- M12600080
- Other IDs
- A5951060
- Status last verified
- Sep 2009
- First submitted
- 14 May 2002
- Last updated
- 14 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections
- ClinicalTrials.gov ID
- NCT00037050
- Acronym / sponsor ID
- M12600080
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Jul 2005 (actual)
- First posted
- 15 May 2002 (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.
This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a central indwelling catheter with signs and symptoms of infection
Key exclusion criteria (5 listed)
- Patients with tunneled catheter which cannot be removed.
- Patients with evidence of endovascular infection including endocarditis.
- Patients with infection of permanent intravascular devices.
- Patients who have received more than 1 day of another antibiotic before enrollment.
- Patients with HIV and low CD4 count.
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 |
|---|---|---|
| LinezolidAlso: Zyvox | Drug | – |
| Vancomycin | Drug | – |
| Oxacillin | Drug | – |
| Dicloxacillin | Drug | – |
Primary outcome
The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;
The empiric treatment of patients with gram-positive catheter-related bloodstream infections.
1 secondary outcome
Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid
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 14 Sep 2009.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Linezolid, Vancomycin and Oxacillin in people with Bacterial Infections and Gram-Positive Bacterial Infections, run by Pfizer.
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 5 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 14 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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 empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;. The study lists 2 primary outcomes in all. 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 14 Sep 2009.