MRSA-ColonizationPhase 2NCT00266448
Whole Body Washing With Chlorhexidine for the Eradication of MRSA
A Phase 2 study testing Chlorhexidine solution 4% in people with MRSA-Colonization, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether whole body washing with chlorhexidine in combination with mupirocine nasal ointment is effective in the eradication of meticillin-resistant Staphylococcus aureus (MRSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA-Colonization
- What is being tested?
- Chlorhexidine solution 4%
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Apr 2004
- Phase
- Phase 2
- 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
- persons who are colonized with MRSA, i.e. one or more cultures from any body site yielded MRSA
Who cannot join
- ongoing systemic or local antimicrobial treatment directed against MRSA
- hypersensitivity to mupirocin or chlorhexidine
- pregnancy
- previous enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Whole Body Washing With Chlorhexidine for the Eradication of MRSA - a Randomized, Placebo-Controlled, Double-Blinded Clinical Trial
The purpose of this study is to determine whether whole body washing with chlorhexidine in combination with mupirocine nasal ointment is effective in the eradication of meticillin-resistant Staphylococcus aureus (MRSA).
Read the detailed description
The number and rate of infections due to meticillin-resistant Staphylococcus aureus (MRSA)is increasing world wide. Patients who are colonized with MRSA are the main source for further distribution. In addition colonization with MRSA is a precondition for infection.
Whole body washing with antiseptic solutions as part of eradication strategies for MRSA has been widely used. However, there is insufficient evidence to support use of topical antimicrobial therapy for eradicating of MRSA because treatment with antiseptic solution has never been compared to placebo.
Comparison: The efficacy of whole body washing in the control of MRSA was studied in a randomized, placebo-controlled, double-blinded clinical trial. The study treatment consisted of five days of whole body washing either with 4% chlorhexidine solution (verum) or with placebo. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9 and 30 days after treatment by swabs taken from several body site.
- Conditions
- MRSA-Colonization
- Being tested
- Chlorhexidine solution 4%
- Keywords
- MRSA, eradication, chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine solution 4%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage
Secondary outcomes (2)
development of MRSA infection
tolerance to the antiseptic whole body treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startJan 2001
- Study completionApr 2004
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 MRSA-ColonizationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Constanze Wendt, MD, MSc, Principal investigator, Hygiene-Institut University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266448
- Sponsor's protocol ID
- 94/2000
- Other IDs
- Projekt-Nr. 384/2000
- Status last verified
- Apr 2004
- First submitted
- 15 Dec 2005
- Last updated
- 16 Dec 2005
- Results posted
- No
Publications
Wendt C, Schinke S, Wurttemberger M, Oberdorfer K, Bock-Hensley O, von Baum H. Value of whole-body washing with chlorhexidine for the eradication of methicillin-resistant Staphylococcus aureus: a randomized, placebo-controlled, double-blind clinical trial. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1036-43. doi: 10.1086/519929. Epub 2007 Jul 3.
PubMed 17932823
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Whole Body Washing With Chlorhexidine for the Eradication of MRSA - a Randomized, Placebo-Controlled, Double-Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT00266448
- Acronym / sponsor ID
- 94/2000
- Conditions
- MRSA-Colonization
- Keywords
- MRSA, eradication, chlorhexidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Apr 2004
- First posted
- 16 Dec 2005 (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 is to determine whether whole body washing with chlorhexidine in combination with mupirocine nasal ointment is effective in the eradication of meticillin-resistant Staphylococcus aureus (MRSA).
Detailed description
The number and rate of infections due to meticillin-resistant Staphylococcus aureus (MRSA)is increasing world wide. Patients who are colonized with MRSA are the main source for further distribution. In addition colonization with MRSA is a precondition for infection.
Whole body washing with antiseptic solutions as part of eradication strategies for MRSA has been widely used. However, there is insufficient evidence to support use of topical antimicrobial therapy for eradicating of MRSA because treatment with antiseptic solution has never been compared to placebo.
Comparison: The efficacy of whole body washing in the control of MRSA was studied in a randomized, placebo-controlled, double-blinded clinical trial. The study treatment consisted of five days of whole body washing either with 4% chlorhexidine solution (verum) or with placebo. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9 and 30 days after treatment by swabs taken from several body site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persons who are colonized with MRSA, i.e. one or more cultures from any body site yielded MRSA
Key exclusion criteria (4 listed)
- ongoing systemic or local antimicrobial treatment directed against MRSA
- hypersensitivity to mupirocin or chlorhexidine
- pregnancy
- previous enrolment
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 |
|---|---|---|
| Chlorhexidine solution 4% | Drug | – |
Primary outcome
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage
2 secondary outcomes
development of MRSA infection
tolerance to the antiseptic whole body treatment
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 16 Dec 2005.
- Derived from this study: PubMed 17932823Wendt C, Schinke S, Wurttemberger M, Oberdorfer K, Bock-Hensley O, von Baum H. Value of whole-body washing with chlorhexidine for the eradication of methicillin-resistant Staphylococcus aureus: a randomized, placebo-controlled, double-blind clinical trial. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1036-43. doi: 10.1086/519929. Epub 2007 Jul 3.
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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.
Constanze Wendt, MD, MSc principal investigator
Hygiene-Institut University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorhexidine solution 4% in people with MRSA-Colonization, run by Heidelberg University at 1 site in Germany.
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 4 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 16 Dec 2005. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00266448, 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 16 Dec 2005; AzTrials last refreshed its copy on 8 Nov 2026.