Nosocomial Infections Clinical Trial
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | February 2004 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou | Rennes | |
France | Service de Réanimation Médicale - Hôpital Bretonneau | Tours |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Ministry of Health, France |
France,
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
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 |
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