Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Louisville
Henry Ford Hospital
Summa Health System
Sparrow Health System
Jackson Memorial Hospital
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01561469
First received: March 21, 2012
Last updated: May 15, 2013
Last verified: May 2013

March 21, 2012
May 15, 2013
November 2008
June 2013   (final data collection date for primary outcome measure)
  • Clinical outcomes: Cured defined as the complete resolution of signs and symptoms of pneumonia; improvement defined as a partial resolution of signs and symptoms of pneumonia; failure defined as the deterioration of signs and symptoms of pneumonia. [ Time Frame: Up to 28 days after the diagnosis of hospital-acquired pneumonia (HAP) ] [ Designated as safety issue: No ]
  • Microbiological outcomes will be defined as: superinfections and colonization (positive cultures with a multi-drug resistant organism). [ Time Frame: Up to 28 days after the diagnosis of HAP ] [ Designated as safety issue: No ]
  • Economic Outcomes: Calculations regarding cost of care for each study arm. [ Time Frame: Up to 28 days after the diagnosis of HAP ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01561469 on ClinicalTrials.gov Archive Site
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Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin

The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes.

Non-randomized, retrospective, observational study

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

This non-interventional study will retrospectively evaluate patients with documented MRSA hospital-acquired including ventilator-associated pneumonia treated with linezolid or vancomycin with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm.

  • Methicillin-Resistant Staphylococcus Aureus (MRSA)
  • Hospital-Acquired Pneumonia
  • Drug: Linezolid
    Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
    Other Name: Zyvox
  • Drug: Vancomycin
    Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.
    Other Name: Vancocin
  • Linezolid observational cohort
    Intervention: Drug: Linezolid
  • Vancomycin observational cohort
    Intervention: Drug: Vancomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients will be enrolled in the study if they fulfill the following three inclusion criteria:

  1. Protocol criteria for HAP/VAP: Criteria for making a correct diagnosis of HAP will be met if the patient develops a new or progressive pulmonary infiltrate associated with at least two of the following: new or increased respiratory symptomatology (cough, sputum or tracheal secretions, shortness of breath), fever or hypothermia, leukocytosis, left shift, or leukopenia, or deterioration of pulmonary function.
  2. Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP
  3. Treatment of MRSA HAP/VAP with either vancomycin or linezolid with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm

Exclusion Criteria:

Patients not meeting enrollment criteria.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01561469
A5951168
No
Pfizer
Pfizer
  • University of Louisville
  • Henry Ford Hospital
  • Summa Health System
  • Sparrow Health System
  • Jackson Memorial Hospital
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP