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| Name | Class |
|---|---|
| University of Louisville | OTHER |
| Henry Ford Hospital | OTHER |
| Summa Health System | OTHER |
| Sparrow Health System |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linezolid observational cohort |
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| Vancomycin observational cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid | Drug | Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days after diagnosis with VAP or hospital discharge, whichever occurred first |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 28 days after diagnosis of VAP |
| Duration of Hospital Stay |
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Inclusion Criteria:
Patients will be enrolled in the study if they fulfill the following three inclusion criteria:
Exclusion Criteria:
Patients not meeting enrollment criteria.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| OTHER |
| Jackson Health System | OTHER |
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| Vancomycin | Drug | Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care. |
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Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital. |
| 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. | 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. | Up to 28 days after diagnosis of VAP |
| Duration of Antimicrobial Treatment | Up to 28 days after diagnosis of VAP |
| Number of Antibiotic Free Days | Up to 28 days after diagnosis of VAP |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis population included all participants who met the eligibility criteria for this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Analysis population included all participants who met the eligibility criteria for this study. | Posted | Number | percentage of participants | 14 days after diagnosis with VAP or hospital discharge, whichever occurred first |
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| 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). | Analysis population included all participants who met the eligibility criteria for this study. | Posted | Number | participants | 28 days after diagnosis of VAP |
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| Secondary | Duration of Hospital Stay | Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital. | Analysis population included all participants who met the eligibility criteria for this study. | Posted | Median | Inter-Quartile Range | days | Up to 28 days after diagnosis of VAP |
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| 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. | Analysis population included all participants who met the eligibility criteria for this study. | Posted | Median | Inter-Quartile Range | days | Up to 28 days after diagnosis of VAP |
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| 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. | Analysis population included all participants who met the eligibility criteria for this study. | Posted | Median | Inter-Quartile Range | days | Up to 28 days after diagnosis of VAP |
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| Secondary | Duration of Antimicrobial Treatment | Analysis population included all participants who met the eligibility criteria for this study. | Posted | Mean | Standard Deviation | days | Up to 28 days after diagnosis of VAP |
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| Secondary | Number of Antibiotic Free Days | 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. | Posted | Up to 28 days after diagnosis of VAP |
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Due to retrospective nature of the study, adverse events data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | ||
| EG001 | 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. | 0 | 0 | 0 | 0 |
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Prioritization of endpoints as primary or secondary was not specified in protocol and was based on study team's inputs.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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