Pneumonia
Conditions
Keywords
MRSA. pneumonia, outcomes
Brief summary
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.
Detailed description
All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.
Interventions
As prescribed-this is retrospective cohort of existing clinical data.
DRUGvancomycin
As prescribed-this is retrospective cohort of existing clinical data.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* MRSA and pneumonia cases by ICD-9 code identification. * Diagnosis included during inpatient stay. * Treatment initiation in hospital.
Exclusion criteria
* Death of discharge within 3 days of treatment initiation. * Exposure to other treatments with MRSA activity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to 30-day Mortality | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge From the Hospital | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date). |
| Time to Transfer Out From the Intensive Care Unit (ICU) | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | 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. |
| Time to Intubation | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date). |
| Time to Therapy Change | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | 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. |
| Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge. |
| Clinical Success | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | 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. |
| Time to 30-day Re-admission | Baseline (1 January 2001) up to 3559 Days (30 September 2010) | Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 328 |
| 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. | 4,943 |
| Total | 5,271 |
Baseline characteristics
| Characteristic | Linezolid | Vancomycin | Total |
|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 12.5 | 69.1 years STANDARD_DEVIATION 12.7 | 69.1 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 5 Participants | 99 Participants | 104 Participants |
| Sex: Female, Male Male | 323 Participants | 4844 Participants | 5167 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
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.
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Time to 30-day Mortality | 15 days |
| Vancomycin | Time to 30-day Mortality | 14 days |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [0.72, 1.2]
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.
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Clinical Success | 50.9 percentage of participants |
| Vancomycin | Clinical Success | 46 percentage of participants |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [1.06, 1.45]
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.
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection | 17 days |
| Vancomycin | Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection | 11 days |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [0.54, 1.48]
Secondary
Time to 30-day Re-admission
Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Time to 30-day Re-admission | 10 days |
| Vancomycin | Time to 30-day Re-admission | 11 days |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [0.68, 1.13]
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).
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Linezolid | Time to Discharge From the Hospital | 19.7 days | Standard Deviation 24.4 |
| Vancomycin | Time to Discharge From the Hospital | 20.3 days | Standard Deviation 26.5 |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [0.9, 1.15]
Secondary
Time to Intubation
Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Time to Intubation | 5 days |
| Vancomycin | Time to Intubation | 3 days |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [0.68, 1.37]
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.
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Time to Therapy Change | 4 days |
| Vancomycin | Time to Therapy Change | 4 days |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [0.53, 1.05]
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.
Time frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Linezolid | Time to Transfer Out From the Intensive Care Unit (ICU) | 2 days |
| Vancomycin | Time to Transfer Out From the Intensive Care Unit (ICU) | 4 days |
Comparison: Propensity Cox proportional hazards regression model was used.95% CI: [0.39, 1.09]