NCT Number: NCT00151606
Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou, Rennes, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
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
Sponsors and collaborators
Lead sponsor
Rennes University Hospital
Other
Collaborators
- Ministry of Health, France
Registry information
Official study title
Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.
Important dates
- Study start
- 2002
- Study completion
- 2004
- First posted
- Sep 9, 2005
- Registry last updated
- Jan 10, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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