An observational study in Pneumonia, sponsored by Pfizer. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-01-30.
Sponsored by Pfizer · Observational
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 5,271 is above the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010
Exclusion Criteria:
Drug: linezolid (Zyvox)
Drug: vancomycin
As prescribed-this is retrospective cohort of existing clinical data.
As prescribed-this is retrospective cohort of existing clinical data.
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)
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)
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)
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)
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)
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)
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)
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)
| Milestone | Linezolid | Vancomycin |
|---|---|---|
| Started | 328 | 4943 |
| Completed | 328 | 4943 |
| Not completed | 0 | 0 |
Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.
| days | Linezolid | Vancomycin |
|---|---|---|
| Time to 30-day Mortality | 15 (3 to 30) | 14 (3 to 30) |
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.
| days | Linezolid | Vancomycin |
|---|---|---|
| Time to Therapy Change | 4 (3 to 6) | 4 (3 to 7) |
Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).
| days | Linezolid | Vancomycin |
|---|---|---|
| Time to Discharge From the Hospital | 19.7 ± 24.4 | 20.3 ± 26.5 |
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.
| days | Linezolid | Vancomycin |
|---|---|---|
| Time to Transfer Out From the Intensive Care Unit (ICU) | 2 (1 to 14) | 4 (1 to 14) |
Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).
| days | Linezolid | Vancomycin |
|---|---|---|
| Time to Intubation | 5 (1 to 59) | 3 (1 to 28) |
Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.
| days | Linezolid | Vancomycin |
|---|---|---|
| Time to 30-day Re-admission | 10 (1 to 30) | 11 (1 to 30) |
Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.
| days | Linezolid | Vancomycin |
|---|---|---|
| Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection | 17 (2 to 30) | 11 (1 to 30) |
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.
| percentage of participants | Linezolid | Vancomycin |
|---|---|---|
| Clinical Success | 50.9 | 46 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Linezolid | — | — | — |
| Vancomycin | — | — | — |
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.
| Age, Continuous(years) | Linezolid | Vancomycin | Total |
|---|---|---|---|
| Mean | 69.1 ± 12.5 | 69.1 ± 12.7 | 69.1 ± 12.7 |
| Sex: Female, Male(Participants) | Linezolid | Vancomycin | Total |
|---|---|---|---|
| Female | 5 | 99 | 104 |
| Male | 323 | 4844 | 5167 |
No study locations are listed for this record.
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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