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Trial record 1 of 1 for:    NCT01819935
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Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia

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ClinicalTrials.gov Identifier: NCT01819935
Recruitment Status : Completed
First Posted : March 28, 2013
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 28, 2013
First Posted Date March 28, 2013
Results First Submitted Date December 12, 2013
Results First Posted Date January 30, 2014
Last Update Posted Date January 30, 2014
Study Start Date December 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2013)
Time to 30-day Mortality [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: March 22, 2013)
30-Day Mortality [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT01819935 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 12, 2013)
  • Time to Therapy Change [ Time Frame: 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 Discharge From the Hospital [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 30-day Re-admission [ Time Frame: 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.
  • Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: March 22, 2013)
  • Time to therapy change [ Time Frame: from index date through discharge ]
  • Hospital discharge [ Time Frame: from index date through discharge ]
  • Transfer out of ICU [ Time Frame: from index date through discharge ]
  • Extubation [ Time Frame: from index date through discharge ]
  • 30-day readmission [ Time Frame: from index date through discharge ]
  • 30-day re-infection [ Time Frame: from index date through discharge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia
Official Title Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010
Condition Pneumonia
Intervention
  • Drug: linezolid (Zyvox)
    As prescribed-this is retrospective cohort of existing clinical data.
  • Drug: vancomycin
    As prescribed-this is retrospective cohort of existing clinical data.
Study Groups/Cohorts
  • linezolid (Zyvox)
    Intervention: Drug: linezolid (Zyvox)
  • Vancomycin
    Intervention: Drug: vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 10, 2013)
5271
Original Actual Enrollment
 (submitted: March 22, 2013)
9814
Actual Study Completion Date January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01819935
Other Study ID Numbers A5951163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2013