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

Last updated on November 7, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Methicillin-Resistant Staphylococcus Aureus (MRSA), Hospital-Acquired Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Patients not meeting enrollment criteria.

NCT01561469
Pfizer
Completed
Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin

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Descriptive Information
Brief TitleEvaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
Official TitleMulticenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin
Brief SummaryThe 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.
Detailed DescriptionNon-randomized, retrospective, observational study
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThis 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.
Condition
  • Methicillin-Resistant Staphylococcus Aureus (MRSA)
  • Hospital-Acquired Pneumonia
Intervention
  • 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
Study Groups/Cohorts
  • Linezolid observational cohort
    Intervention: Drug: Linezolid
  • Vancomycin observational cohort
    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 StatusCompleted
Actual Enrollment
 (submitted: June 9, 2014)
188
Original Estimated Enrollment
 (submitted: March 21, 2012)
200
Actual Study Completion DateJune 2013
Actual Primary Completion DateJune 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01561469
Other Study ID NumbersA5951168
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
Collaborators
  • University of Louisville
  • Henry Ford Hospital
  • Summa Health System
  • Sparrow Health System
  • Jackson Health System
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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