N/A
N=188
Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
Methicillin-Resistant Staphylococcus Aureus (MRSA) · Hospital-Acquired Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT01561469 ↗Enrolled (actual)
188
Serious AEs
—
Results posted
Jul 2014
Primary outcome: Primary: Percentage of Participants With Clinical Success — 85; 69 percentage of participants — p=0.009
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Linezolid (Drug); Vancomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Success |
85; 69 | 0.009 sig |
| SECONDARY Number of Participants With Microbiological Outcome |
42; 37; 34; 32 | 1.00 |
| SECONDARY Duration of Hospital Stay |
18; 16 | 0.773 |
| SECONDARY Duration of Intensive Care Unit (ICU) Stay |
11; 13 | 0.823 |
| SECONDARY Duration of Mechanical Ventilation |
11; 13 | 0.276 |
| SECONDARY Duration of Antimicrobial Treatment |
11; 11 | 0.512 |
| SECONDARY Number of Antibiotic Free Days |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
Patients will be enrolled in the study if they fulfill the following three inclusion criteria:
- 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.
- Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP
- 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.
Data sourced from ClinicalTrials.gov (NCT01561469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.