Selective Digestive Decontamination (SDD) - Selective Orophayngeal Decontamination (SOD) trial

ISRCTN	ISRCTN35176830
DOI	https://doi.org/10.1186/ISRCTN35176830
Protocol serial number	N/A
Sponsor	University Medical Centre Utrecht (Netherlands)
Funder	Dutch SDD Trialists Group (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Anne Marie G A de Smet
Scientific

University Medical Center Utrecht, AZU
PO Box 85500
Amsterdam
3508 GA
Netherlands

Phone	+31 (0)30 2509111
Email	a.desmet@azu.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SDD-SOD-trial
Study objectives	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?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Infection in ICU patients
Intervention	Selective Digestive Decontamination. Selective Oropharyngeal Decontamination.
Intervention type	Other
Primary outcome measure(s)	1. Hospital mortality 2. ICU-mortality
Key secondary outcome measure(s)	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.
Completion date	24/07/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	3450
Key inclusion criteria	All patients admitted to the ICU with an expected stay> 72 hours in ICU or with an expected duration of mechanical ventilation > 48 hours
Key exclusion criteria	1. Known allergy to study-medication in patient-history 2. Pregnancy
Date of first enrolment	01/05/2004
Date of final enrolment	24/07/2006

University Medical Center Utrecht, AZU

Amsterdam
3508 GA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No
Results article	survery results	01/01/2010		Yes	No
Results article	11 results	01/05/2011		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes