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Risk factors for multi-drug resistant P. aeruginosa


- candidate number21822
- NTR NumberNTR5145
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mrt-2015
- Secondary IDsMEC-2015-240 
- Public TitleRisk factors for multi-drug resistant P. aeruginosa
- Scientific TitleIdentifying the Leading Risk Factors for Acquiring VIM-2 Positive Pseudomonas aeruginosa – a Case Control Study
- ACRONYM
- hypothesisThe aim of this study is to analyze the risk-factors associated with acquiring VIM-2 positive P. aeruginosa, among patients admitted to the Erasmus University Medical Center since the first recorded case in 2003. Secondary aims: 1.To investigate whether there is a difference in risk-factors between ICU and non-ICU patients in the Erasmus Medical Center. If that is the case, what are those differences? 2.To investigate whether Diversilab types are associated with specific risk-factors.(E.g. Diversilab types can be associated with medical materials used on various wards (ICU/non-ICU); prior carbapenem use; patient characteristics like age and sex etc.). (For example, males over the age of 50 have a higher odds (x) of acquiring Diversilab type B… when admitted on the ICU.. when having a urinary catheter and so on).
- Healt Condition(s) or Problem(s) studiedPseudomonas aeruginosa, Multi-drug resistant bacteria, Risk factors
- Inclusion criteria• VIM-2 positive culture after 48 hours after admittance in the Erasmus University Medidcal Center.
- Exclusion criteria• Children, because they are admitted at the Sophia Children’s Hospital and are separated from the Erasmus MC facilities. To our knowledge, there is no evidential cross-over potential of VIM-2 positive P. aeruginosa to the adult-care facilities.

• The outbreak resulting from Endoscopic Retrograde Cholangiopancreatography (ERCP). This outbreak has a known cause and is therefore reported and investigated separately (21).

• Patients only admitted at the Erasmus MC Cancer Institute . These patients are cared for in a separate building of the Erasmus MC and are therefore not be included in this study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 25-mrt-2015
- planned closingdate31-aug-2015
- Target number of participants140
- InterventionsNot applicable
- Primary outcomeVIM-2 positive culture of P. auruginosa (infection or colonization)

Absence of VIM-2 positive P. auruginosa (infection or colonization)/culture of P. auruginosa (infection or colonization)
- Secondary outcomeNot appliacble
- TimepointsThe time period in which cases are identified ranges from August 2003 till April 2015.
- Trial web siteNot applicable
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESprof. dr. Margreet C. Vos
- CONTACT for SCIENTIFIC QUERIESprof. dr. Margreet C. Vos
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsVoor in ´t holt AF, Severin JA, Lesaffre EM and Vos MC. A systematic review and meta-analyses show that carbapenem use and medical devices are the leading risk factors for carbapenem-resistant Pseudomonas aeruginosa. Antimicrob Agents Chemother 2014;58:2626-37.
- Brief summaryRationale: Since continuous outbreaks of VIM-2 positive P. aeruginosa occur in the Erasmus MC, additional research is needed to expand our knowledge of VIM-2 positive P. aeruginosa transmission and to identify risk factors applicable to the Erasmus MC, so we can implement targeted prevention strategies in order to stop the outbreaks.
Objective: The main aim of this study is to analyze the risk-factors associated with acquiring VIM-2 positive P. aeruginosa, among patients admitted to the Erasmus University Medical Center since the first recorded case in 2003. The secondary aim is to investigate whether there is a difference in risk-factors between ICU and non-ICU patients in the Erasmus Medical Center. Also, to investigate whether Diversilab types are associated with specific risk-factors.
Study design: Case-control study (observational) Study population: The population consist of adult patients (>=18years) admitted to the Erasmus MC

Main study parameters/endpoints: The main outcomes are: VIM-2 positive culture after 48 hours after admittance in the Erasmus MC (Colonization and infection) and VIM-2 negative colonization and infection
- Main changes (audit trail)
- RECORD23-mrt-2015 - 21-mei-2015


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