Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
NCT01561469
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
Patients not meeting enrollment criteria.
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Descriptive Information | ||||
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Brief Title | Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin | |||
Official Title | Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin | |||
Brief Summary | 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. | |||
Detailed Description | Non-randomized, retrospective, observational study | |||
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 | 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. | |||
Condition |
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Intervention |
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Study Groups/Cohorts |
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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 | 188 | |||
Original Estimated Enrollment | 200 | |||
Actual Study Completion Date | June 2013 | |||
Actual Primary Completion Date | June 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:
Exclusion Criteria: Patients not meeting enrollment criteria. | |||
Sex/Gender |
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Ages | 18 Years and older (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 | NCT01561469 | |||
Other Study ID Numbers | A5951168 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators |
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Investigators |
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PRS Account | Pfizer | |||
Verification Date | June 2014 |