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

Hospital-Acquired Pneumonia Clinical Trial

Official title:

Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561469
• Other study ID #: A5951168
• Status: Completed
• Phase: N/A
• First received: March 21, 2012
• Last updated: June 9, 2014
• Start date: November 2008
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Non-randomized, retrospective, observational study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hospital-Acquired Pneumonia
• Methicillin-Resistant Staphylococcus Aureus (MRSA)
• Pneumonia
• Staphylococcal Infections

Intervention

Drug:
• Linezolid
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
• Vancomycin
Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Pfizer	Henry Ford Hospital, Jackson Memorial Hospital, Sparrow Health System, Summa Health System, University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinical Success	Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.	14 days after diagnosis with VAP or hospital discharge, whichever occurred first	No
Secondary	Number of Participants With Microbiological Outcome	Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).	28 days after diagnosis of VAP	No
Secondary	Duration of Hospital Stay	Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.	Up to 28 days after diagnosis of VAP	No
Secondary	Duration of Intensive Care Unit (ICU) Stay	Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.	Up to 28 days after diagnosis of VAP	No
Secondary	Duration of Mechanical Ventilation	Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.	Up to 28 days after diagnosis of VAP	No
Secondary	Duration of Antimicrobial Treatment		Up to 28 days after diagnosis of VAP	No
Secondary	Number of Antibiotic Free Days		Up to 28 days after diagnosis of VAP	No

External Links

•   To obtain contact information for a study center near you, click here.