Staphylococcal InfectionsNCT00779246
Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections
A study testing Nasal swabs for MRSA culture, Chlorhexidine gluconate and Contact isolation in people with Staphylococcal Infections, run by Christiana Care Health Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Nasal swabs for MRSA culture, Chlorhexidine gluconate and Contact isolation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,518 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion
Who cannot join
- Patient refusal
- Contraindication to nasal swabbing (arm 1)
- Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost-Effectiveness of Chlorhexidine Bathing vs. Active Surveillance Cultures to Prevent Acquisition of Methicillin-resistant Staphylococcus Aureus and Other Hospital-Acquired Infections: A Pilot Study
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).
- Conditions
- Staphylococcal Infections
- Being tested
- Nasal swabs for MRSA culture, Chlorhexidine gluconate, Contact isolation
- Keywords
- Methicillin resistance, Infection control, Staphylococcus aureus, Cross infection, Epidemiology, Chlorhexidine
- Medical subject headings
- Staphylococcal Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabs for MRSA cultureOther
Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.
Chlorhexidine gluconateDrug
Also called Sage 2% Chlorhexidine gluconate cloth
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.
Contact isolationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nasal swabs for MRSA culture; Other: Contact isolation |
| 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. Receives: Other: Nasal swabs for MRSA culture; Drug: Chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During ICU stay
Secondary outcomes (2)
Number of Participants With Central Line Associated Bloodstream Infection
Measured: During ICU stay up to six months
Vancomycin Resistant Enterococcal Infection or Colonization
Measured: During ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Sage Products, Inc.
- Responsible party
- Sponsor
- Investigators
- Marci Drees, MD, MS, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779246
- Sponsor's protocol ID
- 28116
- Status last verified
- Apr 2018
- First submitted
- 22 Oct 2008
- Last updated
- 15 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of Chlorhexidine Bathing vs. Active Surveillance Cultures to Prevent Acquisition of Methicillin-resistant Staphylococcus Aureus and Other Hospital-Acquired Infections: A Pilot Study
- ClinicalTrials.gov ID
- NCT00779246
- Acronym / sponsor ID
- 28116
- Conditions
- Staphylococcal Infections
- Keywords
- Methicillin resistance, Infection control, Staphylococcus aureus, Cross infection, Epidemiology, Chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,518 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Sage Products, Inc.
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 21 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Nasal swabs for MRSA culture, Other: Contact isolationActive 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. |
| 2 | Active comparator | Other: Nasal swabs for MRSA culture, Drug: Chlorhexidine gluconateChlorhexidine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion
Key exclusion criteria (3 listed)
- Patient refusal
- Contraindication to nasal swabbing (arm 1)
- Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal swabs for MRSA culturePatients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU. | Other | 1, 2 |
| Chlorhexidine gluconateAlso: Sage 2% Chlorhexidine gluconate clothCHG-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. | Drug | 2 |
| Contact isolationAll patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation. | Other | 1 |
Primary outcome
Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection
Time frame: During ICU stay
Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).
2 secondary outcomes
Number of Participants With Central Line Associated Bloodstream Infection
Time frame: During ICU stay up to six months
Vancomycin Resistant Enterococcal Infection or Colonization
Time frame: During ICU stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marci Drees, MD, MS principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal swabs for MRSA culture, Chlorhexidine gluconate and Contact isolation in people with Staphylococcal Infections, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection (time frame: During ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.