Trial Outcomes & Findings for Stop Community MRSA Colonization Among Patients (NCT NCT02029872)
NCT ID: NCT02029872
Last Updated: 2018-03-20
Results Overview
Participants were decolonized with a standard Methicillin-resistant Staphylococcus aureus (MRSA) decolonization protocol and monitored for 6 months. This is the number of participants who screened positive for Methicillin-resistant Staphylococcus aureus (MRSA) 6 months after being decolonized (i.e., recurrent infection)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
6 months
Results posted on
2018-03-20
Participant Flow
Recruitment took place from January 2014-March 2015 in an outpatient HIV clinic in Baltimore, Maryland
Enrolled participants were screened for Methicillin-resistant Staphylococcus aureus (MRSA). Only those with a positive MRSA swab in any body site (nares, throat, perineum, rectum, vagina) were randomized to an arm of the study to receive the decolonization protocol.
Participant milestones
| Measure |
Individual Alone
Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
Individual Plus Household
Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stop Community MRSA Colonization Among Patients
Baseline characteristics by cohort
| Measure |
Individual Alone
n=9 Participants
Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
Individual Plus Household
n=9 Participants
Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Cluster of Differentiation 4 (CD4) T-cell count
|
676 cells/mm^3
STANDARD_DEVIATION 451 • n=5 Participants
|
687 cells/mm^3
STANDARD_DEVIATION 223 • n=7 Participants
|
682 cells/mm^3
STANDARD_DEVIATION 345 • n=5 Participants
|
|
HIV Viral Load of <20 detectable copies of HIV viral load
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Only participants who received the decolonization protocol and completed the 6 month follow-up visit (7 for "individual alone' and 6 for 'Individual plus household') were included in the analysis. The rest were lost to follow up
Participants were decolonized with a standard Methicillin-resistant Staphylococcus aureus (MRSA) decolonization protocol and monitored for 6 months. This is the number of participants who screened positive for Methicillin-resistant Staphylococcus aureus (MRSA) 6 months after being decolonized (i.e., recurrent infection)
Outcome measures
| Measure |
Individual Alone
n=7 Participants
Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
Individual Plus Household
n=6 Participants
Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
|---|---|---|
|
Number of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
|
2 Participants
|
3 Participants
|
Adverse Events
Individual Alone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Individual Plus Household
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Individual Alone
n=9 participants at risk
Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
Individual Plus Household
n=9 participants at risk
Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days.
Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching
|
11.1%
1/9 • Number of events 1 • 6 months
|
0.00%
0/9 • 6 months
|
Additional Information
Dr. Jason Farley
Johns Hopkins University School of Nursing
Phone: 4105027563
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place