Pneumonia, Ventilator-AssociatedPhase 4NCT00572559
Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
A Phase 4 study testing Vancomycin and Linezolid in people with Pneumonia, Ventilator-Associated, run by Pfizer at 37 sites in 2 countries.
Trial summary
Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Vancomycin and Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 37 sitesin 2 countries
- Study dates
- Nov 2002to Jan 2005
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have or be suspected of having a ventilator-associated pneumonia (VAP) due to MRSA.
- Patient must be hospitalized for at least 5 days, must be ventilator-dependent ≥ 48 hours prior to screen/baseline, and anticipated to remain on the ventilator for 72 hours after enrollment so follow-up BAL can be performed.
- Clinical picture compatible with pneumonia (acquired during ventilation)
- Chest X Ray at baseline/screen or within 24 hours of initiation of therapy must be consistent with diagnosis of pneumonia
Who cannot join
- Hypersensitivity to linezolid, vancomycin, or one of the excipients in any of these drug formulations.
- Infections due to gram-positive organisms known to be resistant to either of the study drugs.
- Any antibiotic used in the treatment of MRSA, such as vancomycin, TMP/SMX, rifampin, or linezolid, for more than 48 hours prior to patient's enrollment into the study.
- Patients with neutropenia, AIDS, lymphoma or anticipated chemotherapy.
- Patients who have long-term tracheostomy (for more than 60 days). Acute tracheostomy patients are allowed.
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States36 sites
Pfizer Investigational Site
‘Ewa Beach, Hawaii, 96706
Pfizer Investigational Site
Augusta, Georgia, 30909
Pfizer Investigational Site
Buffalo, New York, 14215
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559
Pfizer Investigational Site
Cortland Manor, New York, 10567
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jamaica, New York, 11418
Pfizer Investigational Site
Lexington, Kentucky, 40536
Pfizer Investigational Site
Louisville, Kentucky, 40206
Pfizer Investigational Site
Memphis, Tennessee, 38103
Pfizer Investigational Site
Memphis, Tennessee, 38104
Pfizer Investigational Site
Memphis, Tennessee, 38163
Pfizer Investigational Site
Morgantown, West Virginia, 26505
Pfizer Investigational Site
Nashville, Tennessee, 37212-3375
Pfizer Investigational Site
North East Atlanta, Georgia, 30308
Pfizer Investigational Site
North East Atlanta, Georgia, 30322
Pfizer Investigational Site
North East Atlanta, Georgia, 30329
Pfizer Investigational Site
Norwalk, Connecticut, 06850
Pfizer Investigational Site
Palm Springs, California, 92262
Pfizer Investigational Site
Peoria, Illinois, 61603
Pfizer Investigational Site
Peoria, Illinois, 61636
Pfizer Investigational Site
Peoria, Illinois, 61637
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Phoenix, Arizona, 85012
Pfizer Investigational Site
Rancho Mirage, California, 92270
Pfizer Investigational Site
Redlands, California, 92373
Pfizer Investigational Site
Sacramento, California, 95819
Pfizer Investigational Site
Sacramento, California, 95829
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
Spokane, Washington, 99220
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Waterbury, Connecticut, 06708
Pfizer Investigational Site
Waterbury, Connecticut, 06721
About this study
Official title: A Randomized, Open Label, Multi-Center Clinical Trial, Comparing Microbiologic Response To Linezolid And Vancomycin In Ventilator-Associated Pneumonia (VAP) Due To Methicillin Resistant Staphylococcus Aureus (MRSA)
Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Vancomycin, Linezolid
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
1 gram IV every 12 hours for 7 to 14 days
LinezolidDrug
600 mg every 12 hours (intravenously [IV] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Vancomycin |
| 2 | Experimental | Not described Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin.
Measured: 72-96 hours
Secondary outcomes (5)
To compare duration of mechanical ventilation
Measured: 0000
To compare post treatment tracheal colonization
Measured: FU: 14 days after EOT +/- 2 days
To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)
Measured: EOT: Day 14; FU: 14 days after EOT +/- 2 days
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure
Measured: 72-96 hours
To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU
Measured: EOT: Day 14; FU: 14 days after EOT +/- 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startNov 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 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
- NCT00572559
- Sponsor's protocol ID
- 766-INF-0026-126
- Other IDs
- A5951069
- Status last verified
- Jun 2010
- First submitted
- 11 Dec 2007
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wunderink RG, Mendelson MH, Somero MS, Fabian TC, May AK, Bhattacharyya H, Leeper KV Jr, Solomkin JS. Early microbiological response to linezolid vs vancomycin in ventilator-associated pneumonia due to methicillin-resistant Staphylococcus aureus. Chest. 2008 Dec;134(6):1200-1207. doi: 10.1378/chest.08-0011. Epub 2008 Aug 21.
PubMed 18719064
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multi-Center Clinical Trial, Comparing Microbiologic Response To Linezolid And Vancomycin In Ventilator-Associated Pneumonia (VAP) Due To Methicillin Resistant Staphylococcus Aureus (MRSA)
- ClinicalTrials.gov ID
- NCT00572559
- Acronym / sponsor ID
- 766-INF-0026-126
- Conditions
- Pneumonia, Ventilator-Associated
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jan 2005 (actual)
- First posted
- 13 Dec 2007 (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.
Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vancomycin |
| 2 | Experimental | Drug: Linezolid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have or be suspected of having a ventilator-associated pneumonia (VAP) due to MRSA.
- Patient must be hospitalized for at least 5 days, must be ventilator-dependent ≥ 48 hours prior to screen/baseline, and anticipated to remain on the ventilator for 72 hours after enrollment so follow-up BAL can be performed.
- Clinical picture compatible with pneumonia (acquired during ventilation)
- Chest X Ray at baseline/screen or within 24 hours of initiation of therapy must be consistent with diagnosis of pneumonia
Key exclusion criteria (5 listed)
- Hypersensitivity to linezolid, vancomycin, or one of the excipients in any of these drug formulations.
- Infections due to gram-positive organisms known to be resistant to either of the study drugs.
- Any antibiotic used in the treatment of MRSA, such as vancomycin, TMP/SMX, rifampin, or linezolid, for more than 48 hours prior to patient's enrollment into the study.
- Patients with neutropenia, AIDS, lymphoma or anticipated chemotherapy.
- Patients who have long-term tracheostomy (for more than 60 days). Acute tracheostomy patients are allowed.
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 |
|---|---|---|
| Vancomycin1 gram IV every 12 hours for 7 to 14 days | Drug | 1 |
| Linezolid600 mg every 12 hours (intravenously [IV] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days | Drug | 2 |
Primary outcome
To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin.
Time frame: 72-96 hours
5 secondary outcomes
To compare duration of mechanical ventilation
Time frame: 0000
To compare post treatment tracheal colonization
Time frame: FU: 14 days after EOT +/- 2 days
To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)
Time frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure
Time frame: 72-96 hours
To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU
Time frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days
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 9 Jun 2010.
- Derived from this study: PubMed 18719064Wunderink RG, Mendelson MH, Somero MS, Fabian TC, May AK, Bhattacharyya H, Leeper KV Jr, Solomkin JS. Early microbiological response to linezolid vs vancomycin in ventilator-associated pneumonia due to methicillin-resistant Staphylococcus aureus. Chest. 2008 Dec;134(6):1200-1207. doi: 10.1378/chest.08-0011. Epub 2008 Aug 21.
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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
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin and Linezolid in people with Pneumonia, Ventilator-Associated, run by Pfizer at 37 sites in 2 countries.
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 4 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 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin. (time frame: 72-96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00572559, which also lists 1 linked publication.
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 9 Jun 2010.