Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus.

Nosocomial Infections Clinical Trial

Official title:

Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151606
• Other study ID #: AFSSAPS 020551
• Secondary ID: PHRC/01-07CIC020
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: January 9, 2006
• Start date: December 2002
• Est. completion date: February 2004

Study information

• Verified date: January 2006
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cross Infection
• MRSA Colonization
• Nosocomial Infections
• Staphylococcal Infections

Intervention

Procedure:
• Reinforced isolation + Muciprocine

Locations

Country	Name	City	State
France	Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou	Rennes
France	Service de Réanimation Médicale - Hôpital Bretonneau	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who acquired MRSA at any site during their hospitalization in intensive care unit.
Secondary	- Rate of nosocomial MRSA infections
Secondary	- Rate of nosocomial infections due to other pathogens
Secondary	- Rate of nosocomial infections according to the site
Secondary	- Death rate at the exit of intensive care unit
Secondary	- Additional cost due to reinforced isolation protocol
Secondary	- Antistaphylococcal antibiotics use in both protocols
Secondary	- Number of days of antibiotherapy
Secondary	- Time and cause of septic isolation