Trial Outcomes & Findings for Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance (NCT NCT01209234)
NCT ID: NCT01209234
Last Updated: 2025-11-21
Results Overview
Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2140 participants
Primary outcome timeframe
1 year
Results posted on
2025-11-21
Participant Flow
Recruitment occurred between January 10, 2011 and January 2, 2014, during inpatient admissions in 17 hospitals and 7 nursing homes in Southern California.
Participant milestones
| Measure |
MRSA Decolonization
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
|---|---|---|
|
Overall Study
STARTED
|
1070
|
1070
|
|
Overall Study
COMPLETED
|
1058
|
1063
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
Baseline characteristics by cohort
| Measure |
MRSA Decolonization
n=1058 Participants
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
n=1063 Participants
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
Total
n=2121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 17 • n=68 Participants
|
56 years
STANDARD_DEVIATION 17 • n=76 Participants
|
56 years
STANDARD_DEVIATION 17 • n=48 Participants
|
|
Sex: Female, Male
Female
|
493 Participants
n=68 Participants
|
480 Participants
n=76 Participants
|
973 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
565 Participants
n=68 Participants
|
583 Participants
n=76 Participants
|
1148 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
840 Participants
n=68 Participants
|
844 Participants
n=76 Participants
|
1684 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
132 Participants
n=68 Participants
|
124 Participants
n=76 Participants
|
256 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
47 Participants
n=68 Participants
|
58 Participants
n=76 Participants
|
105 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian
|
6 Participants
n=68 Participants
|
6 Participants
n=76 Participants
|
12 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
20 Participants
n=68 Participants
|
21 Participants
n=76 Participants
|
41 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown/Not Reported
|
13 Participants
n=68 Participants
|
10 Participants
n=76 Participants
|
23 Participants
n=48 Participants
|
|
Region of Enrollment
United States
|
1058 Participants
n=68 Participants
|
1063 Participants
n=76 Participants
|
2121 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Outcomes were analyzed according to the as-treated adherence strata (fully adherent, partially adherent, and nonadherent participant-time)
Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge)
Outcome measures
| Measure |
MRSA Decolonization
n=1058 Participants
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
n=1063 Participants
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
|---|---|---|
|
Time to MRSA Infection
MRSA Infection defined by CDC Criteria
|
67 Participants
|
98 Participants
|
|
Time to MRSA Infection
MRSA Infection defined by Clinical Criteria
|
68 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: 1 yearTime in days to all-cause infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year)
Outcome measures
| Measure |
MRSA Decolonization
n=1058 Participants
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
n=1063 Participants
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
|---|---|---|
|
Time to All-cause Infection (Steering Committee Modified Oct 2011)
All-Cause Infection defined by CDC Criteria
|
207 Participants
|
252 Participants
|
|
Time to All-cause Infection (Steering Committee Modified Oct 2011)
All-Cause Infection defined by Clinical Criteria
|
246 Participants
|
298 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearEvent count of outpatient and inpatient MRSA infections occurring after enrollment
Outcome measures
| Measure |
MRSA Decolonization
n=1058 Participants
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
n=1063 Participants
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
|---|---|---|
|
Number of MRSA Infections
|
67 MRSA Infection Events
|
98 MRSA Infection Events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearNumber of participants experiencing rehospitalization due to MRSA infection (first only)
Outcome measures
| Measure |
MRSA Decolonization
n=1058 Participants
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
n=1063 Participants
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
|---|---|---|
|
Rehospitalization Due to MRSA Infection
|
57 Participants
|
83 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearMedical and non-medical costs of MRSA infection within the 1 year follow up period
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearEvent count of all-cause infections occurring after enrollment
Outcome measures
| Measure |
MRSA Decolonization
n=1058 Participants
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
n=1063 Participants
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
|---|---|---|
|
Number of All-cause Infections
|
207 All-cause infection events
|
252 All-cause infection events
|
Adverse Events
MRSA Decolonization
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Education Arm
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 |
MRSA Decolonization
n=1058 participants at risk
Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
MRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.
|
Education Arm
n=1063 participants at risk
Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.
Standard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Mupirocin (2%)
|
0.47%
5/1058 • Number of events 5 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
0.00%
0/1063 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
|
General disorders
Nasal Mupirocin (2%)
|
0.09%
1/1058 • Number of events 1 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
0.00%
0/1063 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
|
General disorders
Chlorhexidine Mouthwash (0.12%)
|
0.19%
2/1058 • Number of events 2 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
0.00%
0/1063 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
|
Skin and subcutaneous tissue disorders
Chlorhexidine Bodywash (4%)
|
0.09%
1/1058 • Number of events 1 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
0.00%
0/1063 • Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.
|
Additional Information
Susan Huang, Principal Investigator & Medical Director of Epidemiology and Infection Prevention
University of California, Irvine
Phone: 949-824-5073
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place