Throatcarriers of MRSAMESSNCT01269541
MESS-study MRSA Eradication Study Skåne
A study testing Mupirocin and Rifampin+Clindamycine or Trimehoprimsulfa in people with Throatcarriers of MRSA, run by Region Skane at 6 sites in Sweden.
Trial summary
The purpose of this study is to determine whether systemic antibiotic treatment with rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Throatcarriers of MRSA
- What is being tested?
- Mupirocin and Rifampin+Clindamycine or Trimehoprimsulfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 6 sitesSweden
- Study dates
- 1 Mar 2011to 1 May 2015
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Colonized with MRSA in the throat Older than 5 years MRSA-bacteria sensitive for Rifampicin and Clindamycine or Trimethoprimsulfa -
Who cannot join
- Allergy to the studymedication Healthcareworkers Pregnancy Active infection with MRSA Immunosuppression Treatment with other antibiotic during the studyperiod
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Helsingborg hospital
Helsingborg, Skåne County
Kristianstad hospital
Kristianstad, Skåne County
Infectious department SUS Lund
Lund, Skåne County
SUS Malmö
Malmö, Skåne County
Örebro university hospital
Örebro
Karolinska university hospital
Stockholm
About this study
Official title: MESS- MRSA Eradication Study Skåne. A Comparison Between Systemic Antibiotic Treatment in Combination With Topical Mupirocintreatment With Only Topical Mupiroicintreatment to Eradicate MRSA in Throat Carriers
The purpose of this study is to determine whether systemic antibiotic treatment with rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers
- Conditions
- Throatcarriers of MRSA
- Being tested
- Mupirocin, Rifampin+Clindamycine or Trimehoprimsulfa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MupirocinDrug
Topical in the nose 3 times daily for 5 days
Rifampin+Clindamycine or TrimehoprimsulfaDrug
Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2
| Study group | Role | What they receive |
|---|---|---|
| Mupirocin | Active comparator | Topical treatment Receives: Drug: Mupirocin; Drug: Rifampin+Clindamycine or Trimehoprimsulfa |
| Rifampicin+Clindamycine or Trimethoprimsulfa | Active comparator | Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3xVII Trimethoprimsulfa 400mg/80mg 2x2 Receives: Drug: Rifampin+Clindamycine or Trimehoprimsulfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture for MRSA
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study start1 Mar 2011
- Primary completion1 May 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Throatcarriers of 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Melander, MD PHD, Principal investigator, Labmedicin Skåne Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269541
- Sponsor's protocol ID
- MRSA-2010
- Other IDs
- 2010-019727-55
- Acronym
- MESS
- Status last verified
- May 2015
- First submitted
- 3 Jan 2011
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MESS- MRSA Eradication Study Skåne. A Comparison Between Systemic Antibiotic Treatment in Combination With Topical Mupirocintreatment With Only Topical Mupiroicintreatment to Eradicate MRSA in Throat Carriers
- ClinicalTrials.gov ID
- NCT01269541
- Acronym / sponsor ID
- MESS / MRSA-2010
- Conditions
- Throatcarriers of MRSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 4 Jan 2011 (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 systemic antibiotic treatment with rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mupirocin | Active comparator | Drug: Mupirocin, Drug: Rifampin+Clindamycine or TrimehoprimsulfaTopical treatment |
| Rifampicin+Clindamycine or Trimethoprimsulfa | Active comparator | Drug: Rifampin+Clindamycine or TrimehoprimsulfaRifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3xVII Trimethoprimsulfa 400mg/80mg 2x2 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Colonized with MRSA in the throat Older than 5 years MRSA-bacteria sensitive for Rifampicin and Clindamycine or Trimethoprimsulfa -
Key exclusion criteria (1 listed)
- Allergy to the studymedication Healthcareworkers Pregnancy Active infection with MRSA Immunosuppression Treatment with other antibiotic during the studyperiod
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 |
|---|---|---|
| MupirocinTopical in the nose 3 times daily for 5 days | Drug | Mupirocin |
| Rifampin+Clindamycine or TrimehoprimsulfaRifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2 | Drug | Mupirocin, Rifampicin+Clindamycine or Trimethoprimsulfa |
Primary outcome
Culture for MRSA
Time frame: after 6 months
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 22 Aug 2017.
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.
Eva Melander, MD PHD principal investigator
Labmedicin Skåne Malmö
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mupirocin and Rifampin+Clindamycine or Trimehoprimsulfa in people with Throatcarriers of MRSA, run by Region Skane at 6 sites in Sweden.
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 1 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. 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.
What does the primary outcome measure?
Culture for MRSA (time frame: after 6 months). 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 22 Aug 2017.