Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus. - Article
Clinical Trial: Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.
This study has been completed.
|Nosocomial Infections |
| Procedure: Reinforced isolation + Muciprocine |
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Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
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
Expected Total Enrollment: 500
Study start: December 2002; Study completion: September 2005
Last follow-up: February 2004; Data entry closure: July 2004
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.
- Adults over 18 years
- Expected length of stay > 48h in intensive care unit
- Informed written consent
- Cerebral death
- Care limitation
- Documented MRSA on admission
- Patients receiving antistaphylococcal topical antibiotics on admission
Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou, Rennes, 35033, France
Service de Réanimation Médicale - Hôpital Bretonneau, Tours, 37000, France
Christophe Camus, MD, Principal Investigator, Rennes University Hospital
Eric Bellissant, MD, PhD, Study Chair, Rennes University Hospital
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.
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.
Last Updated: September 8, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00151606
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13
- Vancomycin-Intermediate/Resistant Staphylococcus aureus(VISA/VRSA) Infections (Centers for Disease Control and Prevention)