MRSACLEANESTNCT05268120
MRSA Decolonization in Complicated Carriage
A study testing doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. and trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. in people with MRSA, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Multicenter open-label cluster randomized controlled trial determining the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA
- What is being tested?
- doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. and trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jul 2022to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years
- Complicated MRSA carriership. Complicated carriership is defined as having one of the following features: (i) the presence of MRSA located at another site than the nose, (ii) an active infection with MRSA, (iii) in vitro resistance for mupirocin, (iv) active skin lesions, (v) foreign material that connects an internal body site with the outside (e.g., urine catheter, external fixation material), (vi) previously failure of decolonization treatment.
- In case of none of the previously mentioned features, this is considered uncomplicated carriership.
- The ability to provide informed consent for the use of their data.
Who cannot join
- - Presence of any iv-access, urinary catheters or drains (because of high risk of treatment failure)
- Failure of previous decolonization attempt of complicated MRSA carriage
- Allergy or other contra-indication to either doxycycline, rifampicin or trimethoprim (these patients will participate in the observational arm)
- Previous participation in this study (every patient can only participate once)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MRSA Decolonization in Complicated Carriage - Cluster Randomized Trial
Multicenter open-label cluster randomized controlled trial determining the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
Read the detailed description
Rationale: MRSA decolonization has proven to prevent infection and reduce transmission. It has yet remained undecided which combination of anti-staphylococcal agents is most effective in the treatment of complicated MRSA carriage. A recent cohort study showed the highest success rate of decolonization in patients treated with doxycycline-rifampicin (86%) compared to the other antibiotic combinations (average 69%). However, because of the retrospective study design the validity of the results is limited. A randomized clinical study is necessary to determine if doxycycline-rifampicin is superior to other conventional treatment regimens. The Dutch guideline recommends both doxycycline-rifampicin and trimethoprim-rifampicin as first choice treatments for decolonization of complicated MRSA carriage. Therefore trimethoprim-rifampicin will be the comparator of this study.
Objective: To determine the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
Study design: Multicenter open-label cluster randomized controlled trial.
Study population: Adult (>18 years) patients with complicated MRSA carriership, treated at one of the participating outpatient clinics. Sample size 211 patients.
Intervention: Group A: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. versus Group B: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. All orally, total duration 7 days.
Main study parameters/endpoints: The main study endpoint is the success rate of MRSA decolonization. Successful decolonization is defined as 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: MRSA decolonization treatment is already standard clinical practice in the Netherlands. There is no additional burden or risk associated with participation in the study. Both antibiotic regimens (in Group A and Group B) used in the study, are recommended as first-line therapy by the Dutch guideline for the treatment of MRSA carriage. The study is open label, so there is no additional risk of blinding. The number of outpatient visits and follow-up cultures are not different from daily clinical practice in the Netherlands. No invasive procedures will be performed for the purpose of this study.
- Conditions
- MRSA
- Being tested
- doxycycline 200 mg q.d. - rifampicin 600mg b.i.d., trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycycline 200 mg q.d. - rifampicin 600mg b.i.d.Drug
Both first choice treatments in Dutch guideline for MRSA decolonization
trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.Drug
Both first choice treatments in Dutch guideline for MRSA decolonization
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. Receives: Drug: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. |
| B | Active comparator | trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. Receives: Drug: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
success rate of MRSA decolonization
Measured: 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.
Secondary outcomes (1)
long term success rate
success rate of decolonization treatment after 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start25 Jul 2022
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSAStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 211 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, acwestgeest, Leiden University Medical Center
- Investigators
- Merel Lambregts, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268120
- Sponsor's protocol ID
- NL79720.058.21
- Acronym
- CLEANEST
- Status last verified
- Oct 2024
- First submitted
- 24 Feb 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRSA Decolonization in Complicated Carriage - Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05268120
- Acronym / sponsor ID
- CLEANEST / NL79720.058.21
- Conditions
- MRSA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 7 Mar 2022 (actual)
- 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.
Multicenter open-label cluster randomized controlled trial determining the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
Detailed description
Rationale: MRSA decolonization has proven to prevent infection and reduce transmission. It has yet remained undecided which combination of anti-staphylococcal agents is most effective in the treatment of complicated MRSA carriage. A recent cohort study showed the highest success rate of decolonization in patients treated with doxycycline-rifampicin (86%) compared to the other antibiotic combinations (average 69%). However, because of the retrospective study design the validity of the results is limited. A randomized clinical study is necessary to determine if doxycycline-rifampicin is superior to other conventional treatment regimens. The Dutch guideline recommends both doxycycline-rifampicin and trimethoprim-rifampicin as first choice treatments for decolonization of complicated MRSA carriage. Therefore trimethoprim-rifampicin will be the comparator of this study.
Objective: To determine the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
Study design: Multicenter open-label cluster randomized controlled trial.
Study population: Adult (>18 years) patients with complicated MRSA carriership, treated at one of the participating outpatient clinics. Sample size 211 patients.
Intervention: Group A: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. versus Group B: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. All orally, total duration 7 days.
Main study parameters/endpoints: The main study endpoint is the success rate of MRSA decolonization. Successful decolonization is defined as 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: MRSA decolonization treatment is already standard clinical practice in the Netherlands. There is no additional burden or risk associated with participation in the study. Both antibiotic regimens (in Group A and Group B) used in the study, are recommended as first-line therapy by the Dutch guideline for the treatment of MRSA carriage. The study is open label, so there is no additional risk of blinding. The number of outpatient visits and follow-up cultures are not different from daily clinical practice in the Netherlands. No invasive procedures will be performed for the purpose of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d.doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. |
| B | Active comparator | Drug: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Complicated MRSA carriership. Complicated carriership is defined as having one of the following features: (i) the presence of MRSA located at another site than the nose, (ii) an active infection with MRSA, (iii) in vitro resistance for mupirocin, (iv) active skin lesions, (v) foreign material that connects an internal body site with the outside (e.g., urine catheter, external fixation material), (vi) previously failure of decolonization treatment.
- In case of none of the previously mentioned features, this is considered uncomplicated carriership.
- The ability to provide informed consent for the use of their data.
Key exclusion criteria (5 listed)
- - Presence of any iv-access, urinary catheters or drains (because of high risk of treatment failure)
- Failure of previous decolonization attempt of complicated MRSA carriage
- Allergy or other contra-indication to either doxycycline, rifampicin or trimethoprim (these patients will participate in the observational arm)
- Previous participation in this study (every patient can only participate once)
- Pregnancy
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 |
|---|---|---|
| doxycycline 200 mg q.d. - rifampicin 600mg b.i.d.Both first choice treatments in Dutch guideline for MRSA decolonization | Drug | A |
| trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.Both first choice treatments in Dutch guideline for MRSA decolonization | Drug | B |
Primary outcome
success rate
Time frame: 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.
success rate of MRSA decolonization
1 secondary outcome
long term success rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Merel Lambregts, MD PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. and trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. in people with MRSA, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annette Westgeest, MD (+3171 5262613, a.c.westgeest@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.). 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 6 Mar 2025; AzTrials last refreshed its copy on 28 Oct 2026.