N/A
N=463
A Novel Approach to Methicillin-resistant Staphylococcus Aureus (MRSA) Screening of Colonized Patients
MRSA Colonization
Bottom Line
View on ClinicalTrials.gov: NCT01234831 ↗Enrolled (actual)
463
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays — 96.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nucleic acid amplification of nasal swab; nasal swab culture (Device); Nasal swab culture (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays |
96.6 | — |
| PRIMARY Completion of Screening Protocol in Both Trial Arms |
73.7; 9.6 | — |
| PRIMARY Discontinuation of Contact Precautions in Both Trial Arms |
55.2; 86.7 | — |
| SECONDARY Number of Subjects With a Single Positive PCR Result and at Least 1 Positive Culture Assay |
62 | — |
| SECONDARY Sensitivity of First PCR Assay |
93.9 | — |
| SECONDARY Specificity of First PCR Assay. |
92.0 | — |
| SECONDARY Rate of Recolonization or Documented Infection With MRSA |
8 | — |
Summary
Methicillin-resistant Staphylococcus aureus (MRSA) is endemic in hospital settings. Colonization with MRSA puts patients at increased risk for invasive infections, and MRSA infections have been associated with high costs and adverse clinic outcomes. Patients can clear MRSA spontaneously. Improved approaches for identifying patients who are no longer colonized are needed; we hypothesize that more sensitive nucleic acid amplification can be used to improve identification of patients who are no longer colonized.
Eligibility Criteria
Inclusion Criteria
- age > 18
- last positive MRSA culture greater than 3 months old
- admitted to hospital
Exclusion Criteria
- age < 18
- last positive MRSA culture less than or equal to 3 months old
Data sourced from ClinicalTrials.gov (NCT01234831). 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.