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ISRCTN
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ISRCTN35176830
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ClinicalTrials.gov identifier
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Public title
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Selective Digestive Decontamination (SDD) - Selective Orophayngeal Decontamination (SOD) trial
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Scientific title
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Acronym
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SDD-SOD-trial
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Serial number at source
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N/A
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Study hypothesis
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Can mortality in intensive care unit (ICU) patients be reduced by using SDD or SOD as infection prevention measure, without increasing the development of antibiotic resistance?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Infection in ICU patients
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Participants - inclusion criteria
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All patients admitted to the ICU with an expected stay> 72 hours in ICU or with an expected duration of mechanical ventilation > 48 hours
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Participants - exclusion criteria
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1. Known allergy to study-medication in patient-history
2. Pregnancy
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Anticipated start date
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01/05/2004
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Anticipated end date
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24/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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3,450
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Interventions
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Selective Digestive Decontamination.
Selective Oropharyngeal Decontamination.
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Primary outcome measure(s)
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1. Hospital mortality
2. ICU-mortality
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Secondary outcome measure(s)
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1. Prevalence of antibiotic resistance
2. Duration of mechanical ventilation,
3. Duration of ICU-stay,
4. Incidence of hospital infections,
5. Antibiotic use,
6. Health care costs.
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Sources of funding
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Dutch SDD Trialists Group (Netherlands)
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Trial website
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http://jc.med.uu.nl/sdd
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Publications
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1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19118302
2. 2010 survery results in http://www.ncbi.nlm.nih.gov/pubmed/20626848
3. 2911 results in http://www.ncbi.nlm.nih.gov/pubmed/21420908
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Contact name
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Dr
Anne Marie G A
de Smet
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Address
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University Medical Center Utrecht, AZU
PO Box 85500
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City/town
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Amsterdam
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Tel
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+31 (0)30 2509111
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Email
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a.desmet@azu.nl
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Sponsor
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University Medical Centre Utrecht (Netherlands)
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Address
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PO Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Sponsor website:
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http://www.umcutrecht.nl/zorg/
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Date applied
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20/12/2005
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Last edited
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30/03/2011
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Date ISRCTN assigned
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20/12/2005
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