Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01820455
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2013-03-20
Brief Title:
MRSA in a Trauma Population Does Decolonization Prevent Infection
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Methicillin-resistant Staphylococcus Aureus in a Trauma Population Does Decolonization Prevent Infection
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All trauma patients admitted to certain Intensive Care Units ICU will have Methicillin-resistant Staphylococcus aureus MRSA nasal swabs performed to determine MRSA colonization status Only those patients who are determined to be colonized with MRSA at admission will be included in the study All patients must be age 18 and older admitted directly to the ICU from either the Emergency Department or the operating room with trauma-related injuries and must not have active or recent known history of MRSA infections Once patients have been determined to be colonized with MRSA they will be randomized to receive decolonization treatment or placebo Decolonization treatment will include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail routine soap baths and Lubricating Jelly Both groups will be kept on standard contact precautions throughout the course of the study Repeat nasal swabs will be performed at the completion of the treatment regimen to determine the efficacy Patients will be screened for invasive MRSA infections as dictated by their clinical course The primary outcome measure will be invasive MRSA infection rate pneumonia urinary tract infection bacteremia and soft tissue infection Secondary endpoints include hospital lengths of stay ICU lengths of stay mechanical ventilatory support requirements colonization status at the end of treatment and death rates As determined by our power analysis we aim to enroll 75 patients in each arm over the course of 12-24 months
Detailed Description:
Partway through the enrollment period it was determined that in the best interests of the patients the protocol would be altered to eliminate the randomization process and treat all patients with the decolonization treatment regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None