Hospital-Acquired Pneumonia, Methicillin-Resistant Staphylococcus Aureus (MRSA)
Conditions
Keywords
Linezolid, Vancomycin, Ventilator-Associated Pneumonia, Respiratory Tract Infections
Brief 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.
Detailed description
Non-randomized, retrospective, observational study
Interventions
DRUGLinezolid
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
DRUGVancomycin
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.
Sponsors
University of Louisville
Henry Ford Hospital
Summa Health System
Sparrow Health System
Jackson Health System
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be enrolled in the study if they fulfill the following three inclusion criteria: 1. 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. 2. Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP 3. 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
Exclusion criteria
Patients not meeting enrollment criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Success | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Antibiotic Free Days | Up to 28 days after diagnosis of VAP | — |
| Number of Participants With Microbiological Outcome | 28 days after diagnosis of VAP | 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). |
| Duration of Antimicrobial Treatment | Up to 28 days after diagnosis of VAP | — |
| Duration of Intensive Care Unit (ICU) Stay | Up to 28 days after diagnosis of VAP | Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU. |
| Duration of Mechanical Ventilation | Up to 28 days after diagnosis of VAP | Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated. |
| Duration of Hospital Stay | Up to 28 days after diagnosis of VAP | Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Linezolid Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP. | 101 |
| Vancomycin Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \[HAP\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP. | 87 |
| Total | 188 |
Baseline characteristics
| Characteristic | Linezolid | Vancomycin | Total |
|---|---|---|---|
| Age, Continuous | 59 years | 56 years | 57 years |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 76 Participants |
| Sex: Female, Male Male | 63 Participants | 49 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Analysis population included all participants who met the eligibility criteria for this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Percentage of Participants With Clinical Success | 85 percentage of participants |
| Vancomycin | Percentage of Participants With Clinical Success | 69 percentage of participants |
p-value: 0.009Regression, Logistic
Secondary
Duration of Antimicrobial Treatment
Time frame: Up to 28 days after diagnosis of VAP
Population: Analysis population included all participants who met the eligibility criteria for this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Linezolid | Duration of Antimicrobial Treatment | 11 days | Standard Deviation 4 |
| Vancomycin | Duration of Antimicrobial Treatment | 11 days | Standard Deviation 5 |
p-value: 0.512Wilcoxon (Mann-Whitney)
Secondary
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
Population: Analysis population included all participants who met the eligibility criteria for this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Duration of Hospital Stay | 18 days |
| Vancomycin | Duration of Hospital Stay | 16 days |
p-value: 0.773Wilcoxon (Mann-Whitney)
Secondary
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
Population: Analysis population included all participants who met the eligibility criteria for this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Duration of Intensive Care Unit (ICU) Stay | 11 days |
| Vancomycin | Duration of Intensive Care Unit (ICU) Stay | 13 days |
p-value: 0.823Wilcoxon (Mann-Whitney)
Secondary
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
Population: Analysis population included all participants who met the eligibility criteria for this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Duration of Mechanical Ventilation | 11 days |
| Vancomycin | Duration of Mechanical Ventilation | 13 days |
p-value: 0.276Wilcoxon (Mann-Whitney)
Secondary
Number of Antibiotic Free Days
Time frame: Up to 28 days after diagnosis of VAP
Population: Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.
Secondary
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
Population: Analysis population included all participants who met the eligibility criteria for this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Linezolid | Number of Participants With Microbiological Outcome | Superinfections | 42 participants |
| Linezolid | Number of Participants With Microbiological Outcome | Colonization | 34 participants |
| Vancomycin | Number of Participants With Microbiological Outcome | Superinfections | 37 participants |
| Vancomycin | Number of Participants With Microbiological Outcome | Colonization | 32 participants |
Comparison: Analysis for superinfections category reported.p-value: 1Chi-squared
Comparison: Analysis for colonization category reported.p-value: 0.759Chi-squared