Trial Outcomes & Findings for Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections (NCT NCT00779246)
NCT ID: NCT00779246
Last Updated: 2018-05-15
Results Overview
Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1518 participants
Primary outcome timeframe
During ICU stay
Results posted on
2018-05-15
Participant Flow
Participant milestones
| Measure |
Active Surveillance Cultures
Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
|
Chlorhexidine Gluconate (CHG)
Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
|
|---|---|---|
|
Overall Study
STARTED
|
750
|
768
|
|
Overall Study
COMPLETED
|
717
|
715
|
|
Overall Study
NOT COMPLETED
|
33
|
53
|
Reasons for withdrawal
| Measure |
Active Surveillance Cultures
Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
|
Chlorhexidine Gluconate (CHG)
Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
|
|---|---|---|
|
Overall Study
Missing sufficient data for analysis
|
33
|
53
|
Baseline Characteristics
Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections
Baseline characteristics by cohort
| Measure |
Active Surveillance Cultures
n=750 Participants
Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Participants will remain in contact isolation until results return as negative.
|
Chlorhexidine Gluconate (CHG)
n=768 Participants
Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will also be performed but results will be blinded for duration of study and will not be used to determine need for contact isolation.
|
Total
n=1518 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
405 Participants
n=99 Participants
|
438 Participants
n=107 Participants
|
843 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
345 Participants
n=99 Participants
|
330 Participants
n=107 Participants
|
675 Participants
n=206 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 15 • n=99 Participants
|
60 years
STANDARD_DEVIATION 15 • n=107 Participants
|
61 years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
390 Participants
n=99 Participants
|
384 Participants
n=107 Participants
|
774 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
360 Participants
n=99 Participants
|
384 Participants
n=107 Participants
|
744 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
750 participants
n=99 Participants
|
768 participants
n=107 Participants
|
1518 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During ICU stayPopulation: For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.
Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).
Outcome measures
| Measure |
Active Surveillance Cultures (ASC)
n=347 Participants
Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
|
Chlorhexidine Gluconate (CHG)
n=340 Participants
Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
|
|---|---|---|
|
Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection
|
9 participants
|
10 participants
|
SECONDARY outcome
Timeframe: During ICU stay up to six monthsPopulation: For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.
Outcome measures
| Measure |
Active Surveillance Cultures (ASC)
n=347 Participants
Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
|
Chlorhexidine Gluconate (CHG)
n=340 Participants
Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
|
|---|---|---|
|
Number of Participants With Central Line Associated Bloodstream Infection
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: During ICU stayPopulation: For this observational study, subjects were considered at risk for MRSA acquisition if they had no prior history of MRSA, did not have an MRSA infection that was present on admission, and had an ICU length of stay of at least 48 hours.
Outcome measures
| Measure |
Active Surveillance Cultures (ASC)
n=347 Participants
Active surveillance cultures (via nasal swabs) will be performed for all patients admitted to the medical ICU during the designated study period. Patient will remain in contact isolation until results returned as negative.
|
Chlorhexidine Gluconate (CHG)
n=340 Participants
Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures will be performed but results will be blinded and not used to determine need for contact isolation.
|
|---|---|---|
|
Vancomycin Resistant Enterococcal Infection or Colonization
|
7 Participants
|
4 Participants
|
Adverse Events
Active Surveillance Cultures
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chlorhexidine Gluconate (CHG)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place