Inflammatory Bowel DiseaseNCT01918813
Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening
A study testing vancomycin, mupirocin ointment in people with Inflammatory Bowel Disease and Hepatobiliary Disease, run by Chikara Tashiro at 1 site in Japan.
Trial summary
This study was designed to evaluate the effect of a targeted preoperative Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk population undergoing gastroenterological surgery. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Hepatobiliary Disease, Pancreas Disease
- What is being tested?
- vancomycin, mupirocin ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 662 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2009to Feb 2012
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing inflammatory bowel disease (IBD) surgery
- patients undergoing major hepato-biliary-pancreatic surgery
Who cannot join
- emergency surgery,
- age less than 18 years old
- known allergy to mupirocin or chlorhexidine.
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to evaluate the effect of a targeted preoperative Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk population undergoing gastroenterological surgery. The primary endpoint was to investigate whether the potentially high incidence of MRSA infections in patients with MRSA nasal colonization before surgery can be prevented with a PCR-based strategy. The second endpoint was to investigate the impact of acquisition of MRSA colonization after surgery on the occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection is prevented by a targeted screening strategy in preoperative MRSA carrier, and there is limited effect in patients with postoperative MRSA acquisition.
Read the detailed description
Target screening for nasal carriage of MRSA by polymerase chain reaction (PCR) was performed before or on admission. In order to identify MRSA nasal acquisition while on the ward, all patients who were negative before surgery were re-screened every 7 days until discharge. The inclusion criteria for screening were patients undergoing inflammatory bowel disease surgery on ward A, and those undergoing major hepato-biliary-pancreatic surgery on ward B. Investigators classified enrolled patients into preoperative MRSA nasal carriage, postoperative nasal acquisition in patients who were negative for PCR assay before surgery, and non-nasal MRSA carriage during hospitalization. Development of postoperative infections caused by MRSA was assessed according to the nasal MRSA carriage status. MRSA infections rate was also compared between the 2-years of the intervention period and the previous 2-year control period on each ward.
Control measures in identified MRSA carriers consisted of contact precautions, antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA (application of 2% mupirocin ointment twice daily to nares for 5 days and a bath with 4% chlorhexidine daily for 3-5 days). Although contact precautions were used when caring for MRSA-colonized patients, isolation/cohorting was not routinely practiced.
- Being tested
- vancomycin, mupirocin ointment
- Medical subject headings
- Inflammatory Bowel Diseases, Digestive System Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin, mupirocin ointmentDrug
Also called vancomycin, bactroban ointment
contact precautions, topical decolonization of MRSA by a bath with 4% chlorhexidine daily for 3-5 days
| Study group | Role | What they receive |
|---|---|---|
| Preoperative MRSA nasal colonization | Experimental | Interventions in arm of preoperative MRSA nasal colonization consisted of antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA with application of 2% mupirocin ointment twice daily to nares for 5 days Receives: Drug: vancomycin, mupirocin ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization
Measured: Intervention period 2 years
Secondary outcomes (1)
The incidence of MRSA infections between intervention and control period.
Measured: Intervention period 2 years, control period 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startNov 2009
- Primary completionOct 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chikara Tashiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chikara Tashiro, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918813
- Sponsor's protocol ID
- Hyogo college of Medicine 749
- Status last verified
- Aug 2013
- First submitted
- 5 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Methicillin-resistant S.Aureus (MRSA) Infections in MRSA Carrier Under Introduction of Rapid MRSA Screening
- ClinicalTrials.gov ID
- NCT01918813
- Acronym / sponsor ID
- Hyogo college of Medicine 749
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- Chikara TashiroUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Aug 2013 (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.
This study was designed to evaluate the effect of a targeted preoperative Methicillin-resistant Staphylococcus aureus (MRSA) detection by polymerase chain reaction (PCR) on either endogenous or exogenous postoperative MRSA infections in a high risk population undergoing gastroenterological surgery. The primary endpoint was to investigate whether the potentially high incidence of MRSA infections in patients with MRSA nasal colonization before surgery can be prevented with a PCR-based strategy. The second endpoint was to investigate the impact of acquisition of MRSA colonization after surgery on the occurrence of MRSA infections. Investigators hypothesize that postoperative MRSA infection is prevented by a targeted screening strategy in preoperative MRSA carrier, and there is limited effect in patients with postoperative MRSA acquisition.
Detailed description
Target screening for nasal carriage of MRSA by polymerase chain reaction (PCR) was performed before or on admission. In order to identify MRSA nasal acquisition while on the ward, all patients who were negative before surgery were re-screened every 7 days until discharge. The inclusion criteria for screening were patients undergoing inflammatory bowel disease surgery on ward A, and those undergoing major hepato-biliary-pancreatic surgery on ward B. Investigators classified enrolled patients into preoperative MRSA nasal carriage, postoperative nasal acquisition in patients who were negative for PCR assay before surgery, and non-nasal MRSA carriage during hospitalization. Development of postoperative infections caused by MRSA was assessed according to the nasal MRSA carriage status. MRSA infections rate was also compared between the 2-years of the intervention period and the previous 2-year control period on each ward.
Control measures in identified MRSA carriers consisted of contact precautions, antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA (application of 2% mupirocin ointment twice daily to nares for 5 days and a bath with 4% chlorhexidine daily for 3-5 days). Although contact precautions were used when caring for MRSA-colonized patients, isolation/cohorting was not routinely practiced.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative MRSA nasal colonization | Experimental | Drug: vancomycin, mupirocin ointmentInterventions in arm of preoperative MRSA nasal colonization consisted of antibiotic prophylaxis with a single dose of vancomycin 1g in addition to cephalosporins, and topical decolonization of MRSA with application of 2% mupirocin ointment twice daily to nares for 5 days |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing inflammatory bowel disease (IBD) surgery
- patients undergoing major hepato-biliary-pancreatic surgery
Key exclusion criteria (3 listed)
- emergency surgery,
- age less than 18 years old
- known allergy to mupirocin or chlorhexidine.
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 |
|---|---|---|
| vancomycin, mupirocin ointmentAlso: vancomycin, bactroban ointmentcontact precautions, topical decolonization of MRSA by a bath with 4% chlorhexidine daily for 3-5 days | Drug | Preoperative MRSA nasal colonization |
Primary outcome
The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization
Time frame: Intervention period 2 years
1 secondary outcome
The incidence of MRSA infections between intervention and control period.
Time frame: Intervention period 2 years, control period 2 years
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 8 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vancomycin, mupirocin ointment in people with Inflammatory Bowel Disease and Hepatobiliary Disease, run by Chikara Tashiro at 1 site in Japan.
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 2 inclusion and 3 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 8 Aug 2013. 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 Japan. 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?
The incidence of MRSA infections between patients with and without preoperative nasal MRSA colonization (time frame: Intervention period 2 years). 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 8 Aug 2013.