Trial Outcomes & Findings for Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia (NCT NCT01819935)
NCT ID: NCT01819935
Last Updated: 2014-01-30
Results Overview
Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.
COMPLETED
5271 participants
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
2014-01-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
328
|
4943
|
|
Overall Study
COMPLETED
|
328
|
4943
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia
Baseline characteristics by cohort
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
Total
n=5271 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
69.1 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
69.1 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
69.1 years
STANDARD_DEVIATION 12.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
99 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
323 Participants
n=93 Participants
|
4844 Participants
n=4 Participants
|
5167 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.
Outcome measures
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
|---|---|---|
|
Time to 30-day Mortality
|
15 days
Interval 3.0 to 30.0
|
14 days
Interval 3.0 to 30.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
|---|---|---|
|
Time to Therapy Change
|
4 days
Interval 3.0 to 6.0
|
4 days
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: 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.
Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).
Outcome measures
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
|---|---|---|
|
Time to Discharge From the Hospital
|
19.7 days
Standard Deviation 24.4
|
20.3 days
Standard Deviation 26.5
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
|---|---|---|
|
Time to Transfer Out From the Intensive Care Unit (ICU)
|
2 days
Interval 1.0 to 14.0
|
4 days
Interval 1.0 to 14.0
|
SECONDARY outcome
Timeframe: 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.
Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).
Outcome measures
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
|---|---|---|
|
Time to Intubation
|
5 days
Interval 1.0 to 59.0
|
3 days
Interval 1.0 to 28.0
|
SECONDARY outcome
Timeframe: 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.
Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.
Outcome measures
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
|---|---|---|
|
Time to 30-day Re-admission
|
10 days
Interval 1.0 to 30.0
|
11 days
Interval 1.0 to 30.0
|
SECONDARY outcome
Timeframe: 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.
Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.
Outcome measures
| Measure |
Linezolid
n=328 Participants
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.
|
Vancomycin
n=4943 Participants
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.
|
|---|---|---|
|
Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection
|
17 days
Interval 2.0 to 30.0
|
11 days
Interval 1.0 to 30.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Linezolid
n=231 Participants
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.
|
Vancomycin
n=3500 Participants
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.
|
|---|---|---|
|
Clinical Success
|
50.9 percentage of participants
|
46 percentage of participants
|
Adverse Events
Linezolid
Vancomycin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER