Nosocomial InfectionsNCT00151606
Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.
A study testing Reinforced isolation + Muciprocine in people with Nosocomial Infections and MRSA Colonization, run by Rennes University Hospital at 2 sites in France.
Trial summary
Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nosocomial Infections, MRSA Colonization
- What is being tested?
- Reinforced isolation + Muciprocine
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2002to Feb 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years
- Expected length of stay > 48h in intensive care unit
- Informed written consent
Who cannot join
- Cerebral death
- Care limitation
- Neutropenia
- Documented MRSA on admission
- Patients receiving antistaphylococcal topical antibiotics on admission
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou
Rennes, 35033
Service de Réanimation Médicale - Hôpital Bretonneau
Tours, 37000
About this study
Official title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.
Read the detailed description
Recommendations for the prevention of transmission of resistant bacteria in intensive care units (ICU) are rarely based on controlled trials. For this reason, we compared a reinforced isolation precautions protocol (RIPP) with a standard precautions protocol (SPP) for the acquisition of methicillin-resistant Staphylococcus aureus (MRSA) in 2 intensive care units.
Evaluation: the risk for MRSA carriage was defined on admission if 1 of 3 criteria were met: hospitalization in the past year, transfer with prior length of stay ≥2 days, prior history of MRSA in the 5 past years.
Intervention: Randomization 1/1 of a total of 500 patients to either protocol; MRSA screening was performed at the sites of carriage and colonization at inclusion, every week and at ICU discharge in all patients; the results were given to the clinicians only for the patients of the RIPP group.
Protocols: the SPP was consistent with the CDC recommendations and included transmission-based isolation precautions to patients with clinical samples involving resistant bacteria (including MRSA) or highly transmissible organisms. The RIPP included the extension of isolation precautions (1) to patients at risk for MRSA on admission until screening results proved negative and (2) to MRSA-positive patients on screening or clinical samples until further negative samples, in whom nasal mupirocin decontamination was added. Compliance with the recommendations of each protocol was controlled by an audit.
The efficacy is assessed on the proportion of patients who acquired MRSA at any site.
- Conditions
- Nosocomial Infections, MRSA Colonization
- Being tested
- Reinforced isolation + Muciprocine
- Keywords
- Infection prevention, Isolation, Resistant bacteria, MRSA colonization
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforced isolation + MuciprocineProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
Secondary outcomes (8)
- Rate of nosocomial MRSA infections
- Rate of nosocomial infections due to other pathogens
- Rate of nosocomial infections according to the site
- Death rate at the exit of intensive care unit
- Additional cost due to reinforced isolation protocol
- Antistaphylococcal antibiotics use in both protocols
- Number of days of antibiotherapy
- Time and cause of septic isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startDec 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nosocomial InfectionsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Christophe Camus, MD, Principal investigator, Rennes University HospitalEric Bellissant, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151606
- Sponsor's protocol ID
- AFSSAPS 020551
- Other IDs
- PHRC/01-07, CIC0203/010
- Status last verified
- Jan 2006
- First submitted
- 8 Sep 2005
- Last updated
- 10 Jan 2006
- Results posted
- No
Publications
Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999 Nov 10;282(18):1745-51. doi: 10.1001/jama.282.18.1745.
PubMed 10568647Girou E, Pujade G, Legrand P, Cizeau F, Brun-Buisson C. Selective screening of carriers for control of methicillin-resistant Staphylococcus aureus (MRSA) in high-risk hospital areas with a high level of endemic MRSA. Clin Infect Dis. 1998 Sep;27(3):543-50. doi: 10.1086/514695.
PubMed 9770155Camus C, Bellissant E, Sebille V, Perrotin D, Garo B, Legras A, Renault A, Le Corre P, Donnio PY, Gacouin A, Le Tulzo Y, Thomas R. Prevention of acquired infections in intubated patients with the combination of two decontamination regimens. Crit Care Med. 2005 Feb;33(2):307-14. doi: 10.1097/01.ccm.0000152224.01949.01.
PubMed 15699832Camus C, Bellissant E, Legras A, Renault A, Gacouin A, Lavoue S, Branger B, Donnio PY, le Corre P, Le Tulzo Y, Perrotin D, Thomas R. Randomized comparison of 2 protocols to prevent acquisition of methicillin-resistant Staphylococcus aureus: results of a 2-center study involving 500 patients. Infect Control Hosp Epidemiol. 2011 Nov;32(11):1064-72. doi: 10.1086/662180. Epub 2011 Sep 29.
PubMed 22011532
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
- ClinicalTrials.gov ID
- NCT00151606
- Acronym / sponsor ID
- AFSSAPS 020551
- Conditions
- Nosocomial Infections, MRSA Colonization
- Keywords
- Infection prevention, Isolation, Resistant bacteria, MRSA colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Dec 2002
- Study completion
- Feb 2004
- First posted
- 9 Sep 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.
Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.
Detailed description
Recommendations for the prevention of transmission of resistant bacteria in intensive care units (ICU) are rarely based on controlled trials. For this reason, we compared a reinforced isolation precautions protocol (RIPP) with a standard precautions protocol (SPP) for the acquisition of methicillin-resistant Staphylococcus aureus (MRSA) in 2 intensive care units.
Evaluation: the risk for MRSA carriage was defined on admission if 1 of 3 criteria were met: hospitalization in the past year, transfer with prior length of stay ≥2 days, prior history of MRSA in the 5 past years.
Intervention: Randomization 1/1 of a total of 500 patients to either protocol; MRSA screening was performed at the sites of carriage and colonization at inclusion, every week and at ICU discharge in all patients; the results were given to the clinicians only for the patients of the RIPP group.
Protocols: the SPP was consistent with the CDC recommendations and included transmission-based isolation precautions to patients with clinical samples involving resistant bacteria (including MRSA) or highly transmissible organisms. The RIPP included the extension of isolation precautions (1) to patients at risk for MRSA on admission until screening results proved negative and (2) to MRSA-positive patients on screening or clinical samples until further negative samples, in whom nasal mupirocin decontamination was added. Compliance with the recommendations of each protocol was controlled by an audit.
The efficacy is assessed on the proportion of patients who acquired MRSA at any site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over 18 years
- Expected length of stay > 48h in intensive care unit
- Informed written consent
Key exclusion criteria (5 listed)
- Cerebral death
- Care limitation
- Neutropenia
- Documented MRSA on admission
- Patients receiving antistaphylococcal topical antibiotics on admission
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 |
|---|---|---|
| Reinforced isolation + Muciprocine | Procedure or surgery | – |
Primary outcome
Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
8 secondary outcomes
- Rate of nosocomial MRSA infections
- Rate of nosocomial infections due to other pathogens
- Rate of nosocomial infections according to the site
- Death rate at the exit of intensive care unit
- Additional cost due to reinforced isolation protocol
- Antistaphylococcal antibiotics use in both protocols
- Number of days of antibiotherapy
- Time and cause of septic isolation
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 10 Jan 2006.
- Background: PubMed 10568647Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999 Nov 10;282(18):1745-51. doi: 10.1001/jama.282.18.1745.
- Background: PubMed 9770155Girou E, Pujade G, Legrand P, Cizeau F, Brun-Buisson C. Selective screening of carriers for control of methicillin-resistant Staphylococcus aureus (MRSA) in high-risk hospital areas with a high level of endemic MRSA. Clin Infect Dis. 1998 Sep;27(3):543-50. doi: 10.1086/514695.
- Results publication: PubMed 15699832Camus C, Bellissant E, Sebille V, Perrotin D, Garo B, Legras A, Renault A, Le Corre P, Donnio PY, Gacouin A, Le Tulzo Y, Thomas R. Prevention of acquired infections in intubated patients with the combination of two decontamination regimens. Crit Care Med. 2005 Feb;33(2):307-14. doi: 10.1097/01.ccm.0000152224.01949.01.
- Derived from this study: PubMed 22011532Camus C, Bellissant E, Legras A, Renault A, Gacouin A, Lavoue S, Branger B, Donnio PY, le Corre P, Le Tulzo Y, Perrotin D, Thomas R. Randomized comparison of 2 protocols to prevent acquisition of methicillin-resistant Staphylococcus aureus: results of a 2-center study involving 500 patients. Infect Control Hosp Epidemiol. 2011 Nov;32(11):1064-72. doi: 10.1086/662180. Epub 2011 Sep 29.
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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.
Christophe Camus, MD principal investigator
Rennes University Hospital
Eric Bellissant, MD, PhD study chair
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforced isolation + Muciprocine in people with Nosocomial Infections and MRSA Colonization, run by Rennes University Hospital at 2 sites in France.
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 3 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: finished, as of the sponsor's last update on 10 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.. 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 NCT00151606, which also lists 4 linked publications.
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 10 Jan 2006.