An observational study in Methicillin-Resistant Staphylococcus Aureus (MRSA) and Hospital-Acquired Pneumonia, sponsored by Pfizer. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-10.
Sponsored by Pfizer · Observational
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.
Non-randomized, retrospective, observational study
2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.
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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.
Patients will be enrolled in the study if they fulfill the following three inclusion criteria:
Exclusion Criteria:
Patients not meeting enrollment criteria.
Drug: Linezolid
Drug: Vancomycin
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
Also known as: Zyvox
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.
Also known as: Vancocin
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.
Time frame: 14 days after diagnosis with VAP or hospital discharge, whichever occurred first
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
| Milestone | Linezolid | Vancomycin |
|---|---|---|
| Started | 101 | 87 |
| Completed | 101 | 87 |
| Not completed | 0 | 0 |
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.
| percentage of participants | Linezolid | Vancomycin |
|---|---|---|
| Percentage of Participants With Clinical Success | 85 | 69 |
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).
| participants | Linezolid | Vancomycin |
|---|---|---|
| Superinfections | 42 | 37 |
| Colonization | 34 | 32 |
Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.
| days | Linezolid | Vancomycin |
|---|---|---|
| Duration of Hospital Stay | 18 (10 to 28) | 16 (11 to 25.5) |
Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.
| days | Linezolid | Vancomycin |
|---|---|---|
| Duration of Intensive Care Unit (ICU) Stay | 11 (8 to 22) | 13 (8 to 19.5) |
Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.
| days | Linezolid | Vancomycin |
|---|---|---|
| Duration of Mechanical Ventilation | 11 (11 to 24) | 13 (9.5 to 24) |
| days | Linezolid | Vancomycin |
|---|---|---|
| Duration of Antimicrobial Treatment | 11 ± 4 | 11 ± 5 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Linezolid | — | — | — |
| Vancomycin | — | — | — |
Analysis population included all participants who met the eligibility criteria for this study.
| Age, Continuous(years) | Linezolid | Vancomycin | Total |
|---|---|---|---|
| Median | 59 (48 to 68) | 56 (40 to 66) | 57 (45.75 to 68) |
| Sex: Female, Male(Participants) | Linezolid | Vancomycin | Total |
|---|---|---|---|
| Female | 38 | 38 | 76 |
| Male | 63 | 49 | 112 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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