Staphylococcal Infections
Conditions
Keywords
Methicillin resistance, Infection control, Staphylococcus aureus, Cross infection, Epidemiology, Chlorhexidine
Brief summary
This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).
Interventions
OTHERNasal swabs for MRSA culture
Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.
DRUGChlorhexidine gluconate
CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study.
OTHERContact isolation
All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.
Sponsors
Sage Products, Inc.
Christiana Care Health Services
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion
Exclusion criteria
* Patient refusal * Contraindication to nasal swabbing (arm 1) * Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection | During ICU stay | Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture). |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Central Line Associated Bloodstream Infection | During ICU stay up to six months |
| Vancomycin Resistant Enterococcal Infection or Colonization | During ICU stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 750 |
| 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. | 768 |
| Total | 1,518 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing sufficient data for analysis | 33 | 53 |
Baseline characteristics
| Characteristic | Chlorhexidine Gluconate (CHG) | Active Surveillance Cultures | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 330 Participants | 345 Participants | 675 Participants |
| Age, Categorical Between 18 and 65 years | 438 Participants | 405 Participants | 843 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 15 | 61 years STANDARD_DEVIATION 15 | 61 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 768 participants | 750 participants | 1518 participants |
| Sex: Female, Male Female | 384 Participants | 390 Participants | 774 Participants |
| Sex: Female, Male Male | 384 Participants | 360 Participants | 744 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 750 | 0 / 768 |
| serious Total, serious adverse events | 0 / 750 | 0 / 768 |
Outcome results
Primary
Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection
Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).
Time frame: During ICU stay
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Surveillance Cultures (ASC) | Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection | 9 participants |
| Chlorhexidine Gluconate (CHG) | Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection | 10 participants |
Comparison: Null hypothesis was that ASC and CHG would be no different in preventing acquisition of MRSA.p-value: >0.0595% CI: [0.5, 2.9]Regression, Logistic
Secondary
Number of Participants With Central Line Associated Bloodstream Infection
Time frame: During ICU stay up to six months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Surveillance Cultures (ASC) | Number of Participants With Central Line Associated Bloodstream Infection | 5 participants |
| Chlorhexidine Gluconate (CHG) | Number of Participants With Central Line Associated Bloodstream Infection | 3 participants |
Secondary
Vancomycin Resistant Enterococcal Infection or Colonization
Time frame: During ICU stay
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Surveillance Cultures (ASC) | Vancomycin Resistant Enterococcal Infection or Colonization | 7 Participants |
| Chlorhexidine Gluconate (CHG) | Vancomycin Resistant Enterococcal Infection or Colonization | 4 Participants |