Nosocomial BacteremiaNCT00448942
The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections
An observational study of Nosocomial Bacteremia and Nosocomial Fungemia, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 4 sites in United States.
Trial summary
The purpose of this study was to determine if the use of daily chlorhexidine bathing would decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream Infections (BSI) among Intensive Care Unit (ICU) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Bacteremia, Nosocomial Fungemia, MRSA Colonization
- What is being tested?
- Daily bathing with Chlorhexidine based product
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,300 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2004to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
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 adult patients admitted to study units
Who cannot join
- Children under the age of 18
- Previous adverse reaction or documented allergy to chlorhexidine based products
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Hunter Holmes McGuire Veteran Affairs Medical Center
Richmond, Virginia, 23249
Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: The Impact of the Use of Chlorhexidine-Based Bathing System in the Hospital to Reduce the Incidence of MRSA/VRE Infection or Colonization and Nosocomial Bloodstream Infections (BSI)
The purpose of this study was to determine if the use of daily chlorhexidine bathing would decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream Infections (BSI) among Intensive Care Unit (ICU) patients.
Read the detailed description
Infections due to Staphylococci including MRSA are the predominant nosocomially acquired complication in the intensive care unit. The increasing incidence of MRSA colonization and infection among ICU patients has been attributed to many factors including increased admission of patients already colonized with MRSA to the ICU, poor compliance with handwashing and barrier precautions, delayed identification of MRSA colonized patients, and understaffing. Measures that have proven to limit horizontal transmission between patients and staff and staff to patients include strict attention to barrier precautions and handwashing. Unfortunately both of these strategies require levels of compliance that are often not achieved.
Nosocomial blood stream infections are a leading source of morbidity and mortality among intensive care unit patients. Several modifiable factors have been shown to increase the risk of bloodstream infections. These include lapses in the use of strict sterile technique in the insertion of central venous catheters and improper site preparation. New CDC guidelines on the prevention of catheter related bloodstream infections recommend that the preferential use of chlorhexidine containing skin disinfectants be used for site preparation prior to insertion. The use of chlorhexidine reduces residual skin organisms as well as inhibits their rebound growth and has been demonstrated to reduce catheter-associated bloodstream infections in comparison to other skin disinfectant products such as povidone-iodine.
As a result of guidelines promoting the use of chlorhexidine, a number of intensive care units have implemented quality improvement projects examining the potential role of chlorhexidine based bathing of intensive care unit patients in reducing nosocomial transmission of multiresisitant organisms such as MRSA and vancomycin-resistant enterocooci (VRE). The goal of the currently proposed study is to analyse existing data from participating intensive care units that have adopted the use of chlorhexidine antisepsis to determine the impact of chlorhexidine on bacterial colonization and nosocomial infections Participating hospitals who have completed quality improvement projects that included the use of chlorhexidine in bathing of ICU patients will submit de-identified data on nosocomial bacteremias and MRSA and VRE colonization during defined time periods where chlorhexidine bathing was used in comparison to time periods where regular bathing procedures were utilized.
- Conditions
- Nosocomial Bacteremia, Nosocomial Fungemia, MRSA Colonization, MRSA Infection, VRE Colonization, VRE Infection
- Being tested
- Daily bathing with Chlorhexidine based product
- Keywords
- Staphylococcus aureus [B03.510.400.790.750.100], Enterococcus faecalis [B03.510.400.800.280.280], Enterococcus faecium [B03.510.400.800.280.300], Bacteremia [C01.252.100], Fungemia [C01.703.360], Infection Control [G03.850.780.200.450], Antisepsis [G03.850.780.200.450.150]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily bathing with Chlorhexidine based productBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startNov 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial BacteremiaStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 5,300 participants
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Weill Medical College of Cornell University, Washington University School of Medicine, Johns Hopkins University, University of Tennessee, Centers for Disease Control and Prevention
- Investigators
- Edward W Wong, MD, Principal investigator, Hunter Holmes Mcguire Veteran Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448942
- Sponsor's protocol ID
- 01115
- Other IDs
- UR8/CCU315346-03-1
- Status last verified
- Mar 2007
- First submitted
- 15 Mar 2007
- Last updated
- 19 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Use of Chlorhexidine-Based Bathing System in the Hospital to Reduce the Incidence of MRSA/VRE Infection or Colonization and Nosocomial Bloodstream Infections (BSI)
- ClinicalTrials.gov ID
- NCT00448942
- Acronym / sponsor ID
- 01115
- Conditions
- Nosocomial Bacteremia, Nosocomial Fungemia, MRSA Colonization, MRSA Infection, VRE Colonization, VRE Infection
- Keywords
- Staphylococcus aureus [B03.510.400.790.750.100], Enterococcus faecalis [B03.510.400.800.280.280], Enterococcus faecium [B03.510.400.800.280.300], Bacteremia [C01.252.100], Fungemia [C01.703.360], Infection Control [G03.850.780.200.450], Antisepsis [G03.850.780.200.450.150]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,300 participants
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- Weill Medical College of Cornell University, Washington University School of Medicine, Johns Hopkins University, University of Tennessee, Centers for Disease Control and Prevention
- Study start
- Nov 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine if the use of daily chlorhexidine bathing would decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream Infections (BSI) among Intensive Care Unit (ICU) patients.
Detailed description
Infections due to Staphylococci including MRSA are the predominant nosocomially acquired complication in the intensive care unit. The increasing incidence of MRSA colonization and infection among ICU patients has been attributed to many factors including increased admission of patients already colonized with MRSA to the ICU, poor compliance with handwashing and barrier precautions, delayed identification of MRSA colonized patients, and understaffing. Measures that have proven to limit horizontal transmission between patients and staff and staff to patients include strict attention to barrier precautions and handwashing. Unfortunately both of these strategies require levels of compliance that are often not achieved.
Nosocomial blood stream infections are a leading source of morbidity and mortality among intensive care unit patients. Several modifiable factors have been shown to increase the risk of bloodstream infections. These include lapses in the use of strict sterile technique in the insertion of central venous catheters and improper site preparation. New CDC guidelines on the prevention of catheter related bloodstream infections recommend that the preferential use of chlorhexidine containing skin disinfectants be used for site preparation prior to insertion. The use of chlorhexidine reduces residual skin organisms as well as inhibits their rebound growth and has been demonstrated to reduce catheter-associated bloodstream infections in comparison to other skin disinfectant products such as povidone-iodine.
As a result of guidelines promoting the use of chlorhexidine, a number of intensive care units have implemented quality improvement projects examining the potential role of chlorhexidine based bathing of intensive care unit patients in reducing nosocomial transmission of multiresisitant organisms such as MRSA and vancomycin-resistant enterocooci (VRE). The goal of the currently proposed study is to analyse existing data from participating intensive care units that have adopted the use of chlorhexidine antisepsis to determine the impact of chlorhexidine on bacterial colonization and nosocomial infections Participating hospitals who have completed quality improvement projects that included the use of chlorhexidine in bathing of ICU patients will submit de-identified data on nosocomial bacteremias and MRSA and VRE colonization during defined time periods where chlorhexidine bathing was used in comparison to time periods where regular bathing procedures were utilized.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
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 adult patients admitted to study units
Key exclusion criteria (2 listed)
- Children under the age of 18
- Previous adverse reaction or documented allergy to chlorhexidine based products
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 |
|---|---|---|
| Daily bathing with Chlorhexidine based product | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2007.
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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.
Edward W Wong, MD principal investigator
Hunter Holmes Mcguire Veteran Affairs Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Bacteremia and Nosocomial Fungemia, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 4 sites 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 2 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 19 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Mar 2007.