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The purpose of this non-interventional, retrospective study of existing data is to evaluate clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based pneumonia by treatment and among subpopulations.
All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| linezolid (Zyvox) |
| ||
| Vancomycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| linezolid (Zyvox) | Drug | As prescribed-this is retrospective cohort of existing clinical data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to 30-day Mortality | Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases. | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Therapy Change | Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic. |
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Inclusion Criteria:
Exclusion Criteria:
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National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010
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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 who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively. |
| FG001 | Vancomycin | Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full analysis set (FAS) included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.
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| ID | Title | Description |
|---|---|---|
| BG000 | Linezolid | Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to 30-day Mortality | Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases. | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. | Posted | Median | Full Range | days | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
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This retrospective study used participants-level electronic health related databases (e-HRD), in which it was not possible to link (i.e. identify a potential association between) a particular product and medical event for any individual. Thus, adverse events (AEs) were not reportable as individual AE reports.
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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 who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively. |
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Results for 'time to intubation' was reported and not 'time to extubation' due to change in planned analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| vancomycin | Drug | As prescribed-this is retrospective cohort of existing clinical data. |
|
| Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| Time to Discharge From the Hospital | Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date). | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| Time to Transfer Out From the Intensive Care Unit (ICU) | Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU. | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| Time to Intubation | Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date). | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| Time to 30-day Re-admission | Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported. | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection | Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge. | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| Clinical Success | Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported. | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
| BG001 | Vancomycin | Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Vancomycin | Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively. |
|
|
|
| Secondary | Time to Therapy Change | Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic. | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. | Posted | Median | Full Range | days | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
|
|
|
| Secondary | Time to Discharge From the Hospital | Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date). | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. | Posted | Mean | Standard Deviation | days | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
|
|
|
| Secondary | Time to Transfer Out From the Intensive Care Unit (ICU) | Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU. | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. | Posted | Median | Full Range | days | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
|
|
|
| Secondary | Time to Intubation | Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date). | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. | Posted | Median | Full Range | days | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
|
|
|
| Secondary | Time to 30-day Re-admission | Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported. | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. | Posted | Median | Full Range | days | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
|
|
|
| Secondary | Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection | Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge. | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. | Posted | Median | Full Range | days | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
|
|
|
| Secondary | Clinical Success | Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported. | FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of participants | Baseline (1 January 2001) up to 3559 Days (30 September 2010) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Vancomycin | Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively. | 0 | 0 | 0 | 0 |
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.
| 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 |