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| Name | Class |
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| Sage Products, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Active surveillance cultures (ASC) (via nasal swabs) will be performed for all patients admitted to the medical intensive care unit (ICU) during the designated study period. All patients will be placed in contact isolation until nasal swabs return negative; otherwise will remain in isolation. |
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| 2 | Active Comparator | Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures (ASC) will also be used in this arm, but results will be blinded and not used to determine whether patients should be in contact isolation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal swabs for MRSA culture | Other | Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | During ICU stay |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marci Drees, MD, MS | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Hospital | Newark | Delaware | 19718 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Chlorhexidine Gluconate (CHG) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Chlorhexidine gluconate | Drug | 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. |
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| Contact isolation | Other | 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. |
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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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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). | 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. | Posted | Number | participants | During ICU stay |
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| Secondary | Number of Participants With Central Line Associated Bloodstream Infection | 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. | Posted | Number | participants | During ICU stay up to six months |
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| Secondary | Vancomycin Resistant Enterococcal Infection or Colonization | 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. | Posted | Count of Participants | Participants | During ICU stay |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 750 | 0 | 750 | ||
| EG001 | 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. | 0 | 768 | 0 | 768 |
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| Title | Organization | Phone | Extension | |
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| Marci Drees, MD, MS | Christiana Care Health System | 302-733-5602 | mdrees@christianacare.org |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D011790 | Quarantine |
| ID | Term |
|---|---|
| D003140 | Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| >=65 years |
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| Male |
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