MRSA - Methicillin Resistant Staphylococcus Aureus InfectionPhase 4NCT01400308
Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by Methicillin Resistant Staphylococcus Aureus (MRSA)
A Phase 4 study testing Mupirocin + Chlorhexidin and Prontoderm MRSA Kit in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection and MRSA Colonization, run by B. Braun Medical SA at 4 sites in Spain.
Trial summary
Multicenter Clinical Trial, experimental, randomized and prospective study to determine the effectiveness of two protocols addressing the Corporal Decolonization in patients colonized by Methicillin Resistant Staphylococcus Aureus (MRSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA - Methicillin Resistant Staphylococcus Aureus Infection, MRSA Colonization
- What is being tested?
- Mupirocin + Chlorhexidin and Prontoderm MRSA Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 4 sitesSpain
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 4
- 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
- MRSA infected or colonized Patients
Who cannot join
- Patients whose condition or treatment interferes with the proper implementation of the proposed protocols, such as:
- Patients admitted to the ICU
- Patients undergoing resuscitation
- Immobilized patients-avoiding their complete hygiene
- Patients carrying nasogastric tube
- Patients with tracheostomy and / or assisted mechanical ventilation
- Patients who are unable, neither they nor their representatives, to give valid informed consent.
- Patients whose discharged is planned before completing protocol
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital General Universitario de Elche.
Elche, Valencia, 03203
Hospital Clínic Universitari de Valencia.
Valencia, Valencia, 46010
Hospital Arnau de Vilanova
Valencia, Valencia, 46015
About this study
Official title: Clinical Trial to Compare the Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by MRSA (Methicillin Resistant Staphylococcus Aureus)
Multicenter Clinical Trial, experimental, randomized and prospective study to determine the effectiveness of two protocols addressing the Corporal Decolonization in patients colonized by Methicillin Resistant Staphylococcus Aureus (MRSA).
PRIMARY END POINT The aim of this trial is to evaluate the effectiveness of the protocol Prontoderm® in the decolonization of MRSA patients, compared with the protocol of the "Consensus Document and GEIH-SEIMC SEMPSPH" (see attached extract from the document, Annex 7).
Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and currently available in Spain for the same indications proposed in this trial.
Read the detailed description
Design: Multicenter, experimental, randomized and prospective study. The patients were consecutively and alternately assigned to each comparison group. Randomization was assured by central randomization and the first patient to one of the groups and, from there, too centrally, back to each of the two groups.
Group A will be treated with the protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07, as shown listed in Table 4. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days).
Group B will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Ensure the correct application of the treatments without interruption over the weekend indicated protocol.
Sample Calculation: The investigators propose an initial sample of 310 patients for a bilateral approach with a type I error α = 0.05 and β type II error of 20%.
Analysis:
Simple analysis and logistic regression (to adjust for risk factors, sources, concomitant therapy, etc) compared the frequency of decolonization of MRSA, according to sources.
Procedures: To collect information using a standardized form CRD in paper to all hospitals, indicating the parameters listed in this protocol and cultures to be done both baseline and monitoring cultures
DISEASE IN STUDY
This will be treated either or both of the following conditions:
MRSA Colonization: The presence of the organism in the flora of the patient, detected by positive culture for MRSA, and no diagnosis of infection.
MRSA infections: presence of the organism between the flora of the patient, detected by positive culture for MRSA, and the presence of MRSA infection diagnosed according to criteria EPINE 2009 (Annex 8).
- Being tested
- Mupirocin + Chlorhexidin, Prontoderm MRSA Kit
- Keywords
- Methicillin Resistant Staphylococcus Aureus colonization., Methicillin Resistant Staphylococcus Aureus infection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin + ChlorhexidinDrug
Treatment after protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days)
Prontoderm MRSA KitDevice
Treatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics.
Prontoderm® is a Class III medical device
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine + Mupirocin | Active comparator | Will be treated with the protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07, as shown listed in Table 4. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days). Receives: Drug: Mupirocin + Chlorhexidin |
| Prontoderm | Experimental | Will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Receives: Device: Prontoderm MRSA Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decolonization of MRSA patients
The aim of this trial is to evaluate the effectiveness of the protocol "Prontoderm ® in the decolonization of MRSA patients", compared with the protocol of the "Consensus Document and GEIH-SEIMC SEMPSPH" Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and currently available in Spain and all over Europe for the same indications proposed in this trial.
Measured: Final treatment day + 4 (by second control sample)
Secondary outcomes (9)
Percent of decolonization out of total by trained staff treated patients
For both arms, determine the importance of staff training and the proper procedure in the application of hygiene measures, by comparing trial outcomes with same centre historical outcomes regarding MRSA decolonization
Measured: Up to two years
Quantitative (0-10 scale) and qualitative (open questions) measure of the usability of experimental and control products by users
Measure of user satisfaction regarding the usability of the experimental product vs control, by self-administered questionnaire. The fifth and final day of treatment the staff fills out a questionnaire that includes questions about product usability
Measured: The fifth, final day of treatment
Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by staff
Measure of user satisfaction regarding features of the experimental product vs control, by self-administered questionnaire. The fifth and final day of treatment the staff fills out a questionnaire that includes questions about products' features
Measured: The fifth, final day of treatment
Quantitative (0-10 scale) and qualitative (open questions) measure of the organoleptic features of experimental and control products by patients
Measure of patient rating satisfaction regarding the organoleptic features of the experimental product vs control, by self-administered questionnaire.The fifth and final day of treatment the staff fills out a questionnaire that includes questions about product organoleptic features
Measured: The fifth, final day of treatment
Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by patient
Measure of patients' satisfaction regarding features of the experimental product vs control product, by self-administered questionnaire. The fifth and final day of treatment the patient fills out a questionnaire that includes questions about product acceptance
Measured: The fifth, final day of treatment
Percent of decolonization in with Prontoderm® treated multiresistant colonizations decolonization for other multiresistant organisms (not MRSA)
Rate effectiveness of Prontoderm® for other multiresistant organisms (such as Acinetobacter, Pseudomonas, Vancomycin Resistant Enterococcus , E. Coli, Klebsiella and other Enterobacteriaceae producing ESBL).
In the pretreatment culture not only MRSA but also other of the above mentioned bacteria can appear. After finishing treatment, the decolonization of these other bacteria will be assessed (effectiveness of product)
Measured: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured
Incidence and prevalence of multidrug resistant bacteria after experimental vs control treatment
To assess the difference in the appearance of multidrug resistance between both arms
Measured: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured
Delta (decrease or increase) in MRSA epidemiology (incidence, prevalence) for the centre comparing the years before trial and after trial
Mesure of impact of the experimental protocol on the epidemiology by measuring the decrease or increase in MRSA epidemiology (incidence, prevalence) after applying the experimental protocol compared with historical figures from the center- in hospitals where there is a vigilance system for nosocomial infection
Measured: Up to two years
Assess the efficiency (economic impact) of the proposed protocol
Costs of both (experimental and control) treatments will be compared, considering not only price of products, but other MRSA treatment related resources such as staff time, isolation days, etc, to assess the efficiency, economic impact, of the proposed protocol with Prontoderm®, compared with control treatment.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: The differences seen between treatments led to recalculation of the sample, unattainable in a reasonable time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA - Methicillin Resistant Staphylococcus Aureus InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafael Ortí, Dr., Principal investigator, Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400308
- Sponsor's protocol ID
- OPM-G-H-0903
- Status last verified
- Aug 2013
- First submitted
- 19 Jul 2011
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by MRSA (Methicillin Resistant Staphylococcus Aureus)
- ClinicalTrials.gov ID
- NCT01400308
- Acronym / sponsor ID
- OPM-G-H-0903
- Keywords
- Methicillin Resistant Staphylococcus Aureus colonization., Methicillin Resistant Staphylococcus Aureus infection.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The differences seen between treatments led to recalculation of the sample, unattainable in a reasonable time
- Enrolment
- 99 participants (actual)
- Lead sponsor
- B. Braun Medical SAIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jul 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.
Multicenter Clinical Trial, experimental, randomized and prospective study to determine the effectiveness of two protocols addressing the Corporal Decolonization in patients colonized by Methicillin Resistant Staphylococcus Aureus (MRSA).
PRIMARY END POINT The aim of this trial is to evaluate the effectiveness of the protocol Prontoderm® in the decolonization of MRSA patients, compared with the protocol of the "Consensus Document and GEIH-SEIMC SEMPSPH" (see attached extract from the document, Annex 7).
Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and currently available in Spain for the same indications proposed in this trial.
Detailed description
Design: Multicenter, experimental, randomized and prospective study. The patients were consecutively and alternately assigned to each comparison group. Randomization was assured by central randomization and the first patient to one of the groups and, from there, too centrally, back to each of the two groups.
Group A will be treated with the protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07, as shown listed in Table 4. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days).
Group B will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Ensure the correct application of the treatments without interruption over the weekend indicated protocol.
Sample Calculation: The investigators propose an initial sample of 310 patients for a bilateral approach with a type I error α = 0.05 and β type II error of 20%.
Analysis:
Simple analysis and logistic regression (to adjust for risk factors, sources, concomitant therapy, etc) compared the frequency of decolonization of MRSA, according to sources.
Procedures: To collect information using a standardized form CRD in paper to all hospitals, indicating the parameters listed in this protocol and cultures to be done both baseline and monitoring cultures
DISEASE IN STUDY
This will be treated either or both of the following conditions:
MRSA Colonization: The presence of the organism in the flora of the patient, detected by positive culture for MRSA, and no diagnosis of infection.
MRSA infections: presence of the organism between the flora of the patient, detected by positive culture for MRSA, and the presence of MRSA infection diagnosed according to criteria EPINE 2009 (Annex 8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine + Mupirocin | Active comparator | Drug: Mupirocin + ChlorhexidinWill be treated with the protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07, as shown listed in Table 4. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days). |
| Prontoderm | Experimental | Device: Prontoderm MRSA KitWill be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MRSA infected or colonized Patients
Key exclusion criteria (8 listed)
- Patients whose condition or treatment interferes with the proper implementation of the proposed protocols, such as:
- Patients admitted to the ICU
- Patients undergoing resuscitation
- Immobilized patients-avoiding their complete hygiene
- Patients carrying nasogastric tube
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 |
|---|---|---|
| Mupirocin + ChlorhexidinTreatment after protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days) | Drug | Chlorhexidine + Mupirocin |
| Prontoderm MRSA KitTreatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Prontoderm® is a Class III medical device | Device | Prontoderm |
Primary outcome
Decolonization of MRSA patients
Time frame: Final treatment day + 4 (by second control sample)
The aim of this trial is to evaluate the effectiveness of the protocol "Prontoderm ® in the decolonization of MRSA patients", compared with the protocol of the "Consensus Document and GEIH-SEIMC SEMPSPH" Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and currently available in Spain and all over Europe for the same indications proposed in this trial.
9 secondary outcomes
Percent of decolonization out of total by trained staff treated patients
Time frame: Up to two years
Quantitative (0-10 scale) and qualitative (open questions) measure of the usability of experimental and control products by users
Time frame: The fifth, final day of treatment
Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by staff
Time frame: The fifth, final day of treatment
Quantitative (0-10 scale) and qualitative (open questions) measure of the organoleptic features of experimental and control products by patients
Time frame: The fifth, final day of treatment
Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by patient
Time frame: The fifth, final day of treatment
Percent of decolonization in with Prontoderm® treated multiresistant colonizations decolonization for other multiresistant organisms (not MRSA)
Time frame: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured
Incidence and prevalence of multidrug resistant bacteria after experimental vs control treatment
Time frame: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured
Delta (decrease or increase) in MRSA epidemiology (incidence, prevalence) for the centre comparing the years before trial and after trial
Time frame: Up to two years
Assess the efficiency (economic impact) of the proposed protocol
Time frame: Up to two years
Results and safety
The study was stopped early (reason given: The differences seen between treatments led to recalculation of the sample, unattainable in a reasonable time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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.
Rafael Ortí, Dr. principal investigator
Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mupirocin + Chlorhexidin and Prontoderm MRSA Kit in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection and MRSA Colonization, run by B. Braun Medical SA at 4 sites in Spain.
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 8 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: stopped early, as of the sponsor's last update on 2 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 4 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: The differences seen between treatments led to recalculation of the sample, unattainable in a reasonable time). Results are not available in the source record.
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?
Decolonization of MRSA patients (time frame: Final treatment day + 4 (by second control sample)). 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 2 Aug 2013.