MRSA ColonizationNCT01820455
MRSA in a Trauma Population: Does Decolonization Prevent Infection?
A study testing Chlorhexidine, Mupirocin and Soap baths, Lubricating Jelly in people with MRSA Colonization, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA Colonization
- What is being tested?
- Chlorhexidine, Mupirocin and Soap baths, Lubricating Jelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colonized with MRSA at admission
- age of 18 years or older
- admitted directly to the ICU from either the ED or the OR with trauma-related injuries
Who cannot join
- active or recent known history of MRSA infection
- previous institutionalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methicillin-resistant Staphylococcus Aureus in a Trauma Population: Does Decolonization Prevent Infection?
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.
Read the 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.
- Conditions
- MRSA Colonization
- Being tested
- Chlorhexidine, Mupirocin, Soap baths, Lubricating Jelly
- Keywords
- MRSA decolonization, MRSA subtyping, MRSA infection rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine, MupirocinDrug
Also called Hibiclens, Bactroban
Chlorhexidine baths and intranasal mupirocin ointment once daily for five days
Soap baths, Lubricating JellyDrug
Soap and water baths with lubricating jelly to the nares, once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine, Mupirocin | Active comparator | Chlorhexidine baths and intranasal Mupirocin ointment daily for 5 days Receives: Drug: Chlorhexidine, Mupirocin |
| Soap baths, Lubricating jelly | Placebo comparator | Soap and water baths with lubricating jelly to each nare daily for 5 days Receives: Drug: Soap baths, Lubricating Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients decolonized following treatment
Measurement of decolonization of MRSA as determined by polymerase chain reaction (PCR) from the nares of critically ill trauma population following treatment.
Measured: Up to 24 months
Secondary outcomes (2)
Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized
Evaluate the difference between the number of patients who are decolonized following treatment who later develop invasive MRSA infections versus those who remain colonized and develop infections.
Measured: up to 24 months
Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources
Evaluate the genotypes of the initial MRSA sampled and additional sources developed by the patient. This will determine if patients are developing additional infections from outside sources or from the same strain of MRSA with which they were originally colonized.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRSA ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Laura Brown, University of Tennessee
- Investigators
- Robert A Maxwell, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820455
- Sponsor's protocol ID
- NTI-TRA-10-020
- Status last verified
- Dec 2014
- First submitted
- 20 Mar 2013
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Croft CA, Mejia VA, Barker DE, Maxwell RA, Dart BW, Smith PW, Burns RP. Methicillin-resistant Staphylococcus aureus in a trauma population: does colonization predict infection? Am Surg. 2009 Jun;75(6):458-61; discussion 461-2.
PubMed 19545092
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methicillin-resistant Staphylococcus Aureus in a Trauma Population: Does Decolonization Prevent Infection?
- ClinicalTrials.gov ID
- NCT01820455
- Acronym / sponsor ID
- NTI-TRA-10-020
- Conditions
- MRSA Colonization
- Keywords
- MRSA decolonization, MRSA subtyping, MRSA infection rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine, Mupirocin | Active comparator | Drug: Chlorhexidine, MupirocinChlorhexidine baths and intranasal Mupirocin ointment daily for 5 days |
| Soap baths, Lubricating jelly | Placebo comparator | Drug: Soap baths, Lubricating JellySoap and water baths with lubricating jelly to each nare daily for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- colonized with MRSA at admission
- age of 18 years or older
- admitted directly to the ICU from either the ED or the OR with trauma-related injuries
Key exclusion criteria (2 listed)
- active or recent known history of MRSA infection
- previous institutionalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine, MupirocinAlso: Hibiclens, BactrobanChlorhexidine baths and intranasal mupirocin ointment once daily for five days | Drug | Chlorhexidine, Mupirocin |
| Soap baths, Lubricating JellySoap and water baths with lubricating jelly to the nares, once daily for 5 days | Drug | Soap baths, Lubricating jelly |
Primary outcome
Number of patients decolonized following treatment
Time frame: Up to 24 months
Measurement of decolonization of MRSA as determined by polymerase chain reaction (PCR) from the nares of critically ill trauma population following treatment.
2 secondary outcomes
Number of decolonized patients who develop further infections versus number of infections developed by patients who remain colonized
Time frame: up to 24 months
Evaluate the genotype and virulence factors of initial colonization and additional MRSA sources
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Background: PubMed 19545092Croft CA, Mejia VA, Barker DE, Maxwell RA, Dart BW, Smith PW, Burns RP. Methicillin-resistant Staphylococcus aureus in a trauma population: does colonization predict infection? Am Surg. 2009 Jun;75(6):458-61; discussion 461-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Maxwell, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine, Mupirocin and Soap baths, Lubricating Jelly in people with MRSA Colonization, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients decolonized following treatment (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.