Methicillin-Resistant Staphylococcus Aureus (MRSA)NCT01561469
Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
An observational study of Methicillin-Resistant Staphylococcus Aureus (MRSA) and Hospital-Acquired Pneumonia, run by Pfizer.
Trial summary
The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus (MRSA), Hospital-Acquired Pneumonia
- What is being tested?
- Linezolid and Vancomycin
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jun 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: This non-interventional study will retrospectively evaluate patients with documented MRSA hospital-acquired including ventilator-associated pneumonia treated with linezolid or vancomycin with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm.
Who may be able to join
- Patients will be enrolled in the study if they fulfill the following three inclusion criteria:
- Protocol criteria for HAP/VAP: Criteria for making a correct diagnosis of HAP will be met if the patient develops a new or progressive pulmonary infiltrate associated with at least two of the following: new or increased respiratory symptomatology (cough, sputum or tracheal secretions, shortness of breath), fever or hypothermia, leukocytosis, left shift, or leukopenia, or deterioration of pulmonary function.
- Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP
- Treatment of MRSA HAP/VAP with either vancomycin or linezolid with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm
Who cannot join
- Patients not meeting enrollment criteria.
About this study
Official title: Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin
The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes.
Read the detailed description
Non-randomized, retrospective, observational study
- Being tested
- Linezolid, Vancomycin
- Keywords
- Linezolid, Vancomycin, Ventilator-Associated Pneumonia, Respiratory Tract Infections
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
Also called Zyvox
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
VancomycinDrug
Also called Vancocin
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.
| Study group | Role | What they receive |
|---|---|---|
| Linezolid observational cohort | Not described Receives: Drug: Linezolid | |
| Vancomycin observational cohort | Not described Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Success
Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.
Measured: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first
Secondary outcomes (6)
Number of Participants With Microbiological Outcome
Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).
Measured: 28 days after diagnosis of VAP
Duration of Hospital Stay
Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.
Measured: Up to 28 days after diagnosis of VAP
Duration of Intensive Care Unit (ICU) Stay
Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.
Measured: Up to 28 days after diagnosis of VAP
Duration of Mechanical Ventilation
Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.
Measured: Up to 28 days after diagnosis of VAP
Duration of Antimicrobial Treatment
Measured: Up to 28 days after diagnosis of VAP
Number of Antibiotic Free Days
Measured: Up to 28 days after diagnosis of VAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startNov 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methicillin-Resistant Staphylococcus Aureus (MRSA)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Louisville, Henry Ford Hospital, Summa Health System, Sparrow Health System, Jackson Health System
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561469
- Sponsor's protocol ID
- A5951168
- Status last verified
- Jun 2014
- First submitted
- 21 Mar 2012
- Last updated
- 10 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin
- ClinicalTrials.gov ID
- NCT01561469
- Acronym / sponsor ID
- A5951168
- Keywords
- Linezolid, Vancomycin, Ventilator-Associated Pneumonia, Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- University of Louisville, Henry Ford Hospital, Summa Health System, Sparrow Health System, Jackson Health System
- Study start
- Nov 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 10 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes.
Detailed description
Non-randomized, retrospective, observational study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linezolid observational cohort | – | Drug: Linezolid |
| Vancomycin observational cohort | – | Drug: Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This non-interventional study will retrospectively evaluate patients with documented MRSA hospital-acquired including ventilator-associated pneumonia treated with linezolid or vancomycin with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm.
Key inclusion criteria (4 listed)
- Patients will be enrolled in the study if they fulfill the following three inclusion criteria:
- Protocol criteria for HAP/VAP: Criteria for making a correct diagnosis of HAP will be met if the patient develops a new or progressive pulmonary infiltrate associated with at least two of the following: new or increased respiratory symptomatology (cough, sputum or tracheal secretions, shortness of breath), fever or hypothermia, leukocytosis, left shift, or leukopenia, or deterioration of pulmonary function.
- Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP
- Treatment of MRSA HAP/VAP with either vancomycin or linezolid with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm
Key exclusion criteria (1 listed)
- Patients not meeting enrollment criteria.
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: ZyvoxPatients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care. | Drug | Linezolid observational cohort |
| VancomycinAlso: VancocinPatients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care. | Drug | Vancomycin observational cohort |
Primary outcome
Percentage of Participants With Clinical Success
Time frame: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first
Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.
6 secondary outcomes
Number of Participants With Microbiological Outcome
Time frame: 28 days after diagnosis of VAP
Duration of Hospital Stay
Time frame: Up to 28 days after diagnosis of VAP
Duration of Intensive Care Unit (ICU) Stay
Time frame: Up to 28 days after diagnosis of VAP
Duration of Mechanical Ventilation
Time frame: Up to 28 days after diagnosis of VAP
Duration of Antimicrobial Treatment
Time frame: Up to 28 days after diagnosis of VAP
Number of Antibiotic Free Days
Time frame: Up to 28 days after diagnosis of VAP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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?
An observational study of Methicillin-Resistant Staphylococcus Aureus (MRSA) and Hospital-Acquired Pneumonia, 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 4 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 Jul 2014. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Clinical Success (time frame: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first). 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 Jul 2014.