Clinical trial NCT00151606: Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.
Official title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nosocomial Infections
MRSA Colonization
Keywords: Infection prevention
Isolation
Resistant bacteria
MRSA colonization
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Adults over 18 years
* Expected length of stay \> 48h in intensive care unit
* Informed written consent

Exclusion Criteria:

* Cerebral death
* Care limitation
* Neutropenia
* Documented MRSA on admission
* Patients receiving antistaphylococcal topical antibiotics on admission

Primary outcomes:
measure: Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
Secondary outcomes:
measure: - Rate of nosocomial MRSA infections
measure: - Rate of nosocomial infections due to other pathogens
measure: - Rate of nosocomial infections according to the site
measure: - Death rate at the exit of intensive care unit
measure: - Additional cost due to reinforced isolation protocol
measure: - Antistaphylococcal antibiotics use in both protocols
measure: - Number of days of antibiotherapy
measure: - Time and cause of septic isolation
Other outcomes:
Locations:
city: Rennes
country: France
facility: Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou
city: Tours
country: France
facility: Service de Réanimation Médicale - Hôpital Bretonneau
Study officials:
affiliation: Rennes University Hospital
name: Christophe Camus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes University Hospital
name: Eric Bellissant, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Girou 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.
citation: Camus 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.
citation: Camus 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.