Nosocomial BacteremiaCBETNCT00502476
Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections
An observational study of Nosocomial Bacteremia and MRSA Colonization, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 7 sites in United States.
Trial summary
To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Bacteremia, MRSA Colonization, MRSA Infection
- What is being tested?
- Bathing with Chlorhexidine Impregnated Washcloths
- Type of treatment
- Surgery or procedure
- How many people
- 14,000 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2007to Sep 2009
- 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 patients admitted to study units during the proposed study interval are eligible for inclusion in the study
Who cannot join
- Patients with known allergies to chlorhexidine gluconate or any other ingredients in the product
- Patients with burns that include a high percentage of disrupted body surface area
- Use in patients undergoing lumbar punctures or contact with the meninges
- Patients with large open skin wounds; and
- Children less than 18 years old
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Trish M Perl, MD, MSc, 410-955-8384, tperl@jhmi.edu
Kathleen Speck, (410) 614-6206, kspeck2@JHMI.EDU
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Debbie Yokoe, MD, MPH, 617-525-2689, dyokoe@partners.org
Debbie Yokoe, MD, MPH
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Maureen K Bolon, MD, 312-695-5059, m-bolon@NORTHWESTERN.EDU
Farida Siddiqui, 312-926-3693, f-siddiqui2@northwestern.edu
- Not yet recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1081
Loreen Herwaldt, MD, 319-356-0474, loreen-herwaldt@UIOWA.EDU
Loreen Herwaldt, MD
- Not yet recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Kent A Sepkowitz, MD, sepkowik@MSKCC.ORG
Kate Gase, MPH, gasek@MSKCC.ORG
- Recruiting
Hunter Holmes McGuire Veteran Affairs Medical Center
Richmond, Virginia, 23249
Michael W Climo, MD, 804-675-5018, michael.climo@va.gov
Edward S Wong, MD, (804) 675-6792, edward.wong@va.gov
- Not yet recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Dave K Warren, MD, DWARREN@IM.WUSTL.EDU
Liana Merz, lmerz@im.wustl.edu
About this study
Official title: Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE
To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.
Read the detailed description
This is a cluster randomized, crossover-controlled trial with wards as the units of randomization. The trial will predominantly take place in ICU's but may include any acute care ward that has active surveillance for MRSA and or VRE in place (i.e., Bone Marrow transplant units, Oncology wards, etc.) Units will be randomly assigned to utilize two bathing routines in a random order. Each bathing routine will be utilized on all admitted patients to the unit for a six month study period for a total study duration of 12 months. The two bathing routines will include either the use of the Comfort® Bath Washcloth System (control) or the use of 2% Chlorhexidine Gluconate Cloth. Randomized units will either start with 2% Chlorhexidine Gluconate Cloth for six months and then switch to Comfort™ Bath Washcloth for the remaining six month period or the reverse order. Data collection will include all surveillance and clinical cultures for MRSA and or VRE and all bloodstream infections.
- Being tested
- Bathing with Chlorhexidine Impregnated Washcloths
- Keywords
- MRSA, VRE, BSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bathing with Chlorhexidine Impregnated WashclothsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startAug 2007
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 14,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Centers for Disease Control and Prevention, Sage Products, Inc.
- Investigators
- Michael W Climo, MD, Study director, Hunter Holmes Mcguire Veteran Affairs Medical CenterEdward S Wong, MD, Principal investigator, Hunter Holmes Mcguire Veteran Affairs Medical CenterJane A Cecil, MD, Principal investigator, Hunter Holmes Mcguire Veteran Affairs Medical CenterKent Sepkowitz, MD, Principal investigator, Weil Medical College of Cornell UniversityTrish M Perl, MD, MSc, Principal investigator, Johns Hopkins UniversityDebbie Yokoe, MD, MPH, Principal investigator, Harvard School of Medicine, Brigham and Women's HospitalMaureen Bolon, MD, Principal investigator, Northwestern UniversityDave K Warren, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502476
- Sponsor's protocol ID
- CI06-003
- Acronym
- CBET
- Status last verified
- Aug 2007
- First submitted
- 16 Jul 2007
- Last updated
- 7 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Climo MW, Yokoe DS, Warren DK, Perl TM, Bolon M, Herwaldt LA, Weinstein RA, Sepkowitz KA, Jernigan JA, Sanogo K, Wong ES. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013 Feb 7;368(6):533-42. doi: 10.1056/NEJMoa1113849.
PubMed 23388005
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE
- ClinicalTrials.gov ID
- NCT00502476
- Acronym / sponsor ID
- CBET / CI06-003
- Keywords
- MRSA, VRE, BSI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14,000 participants (estimated)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Collaborators
- Centers for Disease Control and Prevention, Sage Products, Inc.
- Study start
- Aug 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 17 Jul 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.
To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.
Detailed description
This is a cluster randomized, crossover-controlled trial with wards as the units of randomization. The trial will predominantly take place in ICU's but may include any acute care ward that has active surveillance for MRSA and or VRE in place (i.e., Bone Marrow transplant units, Oncology wards, etc.) Units will be randomly assigned to utilize two bathing routines in a random order. Each bathing routine will be utilized on all admitted patients to the unit for a six month study period for a total study duration of 12 months. The two bathing routines will include either the use of the Comfort® Bath Washcloth System (control) or the use of 2% Chlorhexidine Gluconate Cloth. Randomized units will either start with 2% Chlorhexidine Gluconate Cloth for six months and then switch to Comfort™ Bath Washcloth for the remaining six month period or the reverse order. Data collection will include all surveillance and clinical cultures for MRSA and or VRE and all bloodstream infections.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
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 study units during the proposed study interval are eligible for inclusion in the study
Key exclusion criteria (5 listed)
- Patients with known allergies to chlorhexidine gluconate or any other ingredients in the product
- Patients with burns that include a high percentage of disrupted body surface area
- Use in patients undergoing lumbar punctures or contact with the meninges
- Patients with large open skin wounds; and
- Children less than 18 years old
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 |
|---|---|---|
| Bathing with Chlorhexidine Impregnated Washcloths | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2007.
- Derived from this study: PubMed 23388005Climo MW, Yokoe DS, Warren DK, Perl TM, Bolon M, Herwaldt LA, Weinstein RA, Sepkowitz KA, Jernigan JA, Sanogo K, Wong ES. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013 Feb 7;368(6):533-42. doi: 10.1056/NEJMoa1113849.
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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.
Michael W Climo, MD study director
Hunter Holmes Mcguire Veteran Affairs Medical Center
Edward S Wong, MD principal investigator
Hunter Holmes Mcguire Veteran Affairs Medical Center
Jane A Cecil, MD principal investigator
Hunter Holmes Mcguire Veteran Affairs Medical Center
7 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 MRSA Colonization, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 7 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 5 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: status not confirmed, as of the sponsor's last update on 7 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael W Climo, MD ((804) 675-5018, michael.climo@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00502476, which also lists 1 linked publication.
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 7 Aug 2007.