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Antibiotic resistance after usage of Selective Decontamination of the Digestive tract (SDD) or Selective Oropharyngeal Decontamination (SOD).


- candidate number11238
- NTR NumberNTR3311
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-feb-2012
- Secondary IDs10 V006 CME LUMC
- Public TitleAntibiotic resistance after usage of Selective Decontamination of the Digestive tract (SDD) or Selective Oropharyngeal Decontamination (SOD).
- Scientific TitleResistant gram negative bacteria after cessation of Selective Decontamination of the Digestive Tract (SDD) or Selective Oropharyngeal Decontamination (SOD) in ICU patients.
- ACRONYMRecolonisation trial
- hypothesisUsage of SDD or SOD has been shown to reduce the incidence of ventilator associated pneumonia (VAP) and to improve patient survival. SDD and SOD were shown not to increase resistance of bacteria colonizing the digestive tract. It can not be excluded that antibiotics in the faeces suppress the growth of resistant bacteria during SDD, and that those resistant strains may quickly re-emerge after discontinuation of SDD. The rate of re-colonization with resistant enteral bacterial flora after cessation of SDD or SOD is currently unknown.
To determine factors associated with emergence and persistence of pathogenic Gram-negative bacteria and to assess the rate of return of resistant enteral bacterial flora after treatment with SDD or SOD a follow-up study will be performed of rectal cultures of patients after discharge from the ICU at determined intervals.
- Healt Condition(s) or Problem(s) studiedAntimicrobial resistance, Selective Decontamination of the Digestive tract (SDD), Selective Oropharyngeal Decontamination (SOD), Intensive care
- Inclusion criteriaAll adult ICU patients treated with either SDD or SOD for more than 4 days (96hrs).
- Exclusion criteria1. Patients younger than 18 years of age;
2. Patients treated with enteral antibiotics other than SDD or SOD during ICU-stay.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jun-2010
- planned closingdate31-dec-2012
- Target number of participants1240
- InterventionsRectal cultures after usage of either Selective Decontamination of the Digestive tract (SDD) or Selective Oropharyngeal Decontamination (SOD).
- Primary outcomeRectal colonization with any resistant aerobic Gram-negative bacteria at any time point within 10 days after ICU discharge.
- Secondary outcomeN/A
- TimepointsDays 0, 3, 6 and 10 after discharge form the ICU.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. E.H.R. Essen, van
- CONTACT for SCIENTIFIC QUERIESMD. E.H.R. Essen, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD28-feb-2012 - 9-mrt-2012


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