|- candidate number||1395|
|- NTR Number||NTR278|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||SDD-SOD-trial.|
|- Scientific Title||Selective Digestive Decontamination (SDD) and Selective Orophayngeal Decontamination (SOD) as Infection Prevention Measure in Intensive Care: |
Effects on Mortality and Antibiotic Resistance Development.
|- hypothesis||Can mortality in ICU-patients be reduced by using SDD or SOD as infection prevention measure, without increasing the development of antibiotic resistance.|
|- Healt Condition(s) or Problem(s) studied||Intensive Care (IC) patients|
|- 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.|
|- Exclusion criteria||1. Known allergy to study-medication in patient-history;|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2004|
|- planned closingdate||24-jul-2006|
|- Target number of participants||3450|
|- Interventions||Selective Digestive Decontamination.|
Selective Oropharyngeal Decontamination.
|- Primary outcome||1. Hospital mortality;|
|- Secondary outcome||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.
|- Trial web site||http://jc.med.uu.nl/sdd|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Anne Marie G.A. Smet, de|
|- CONTACT for SCIENTIFIC QUERIES|| Anne Marie G.A. Smet, de|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), AZU|
(Source(s) of Monetary or Material Support)
|Dutch SDD Trialists Group|
|- Brief summary||Most ICU-acquired infections are caused by aerobic potentially pathogenic microoorganisms (PPM), usually after the development of colonisation. Colonisation with PPM occurs rapidly in the majority of patients. |
The reservoirs of these bacteria are the digestive tract, other colonized patients and contaminated environments. Antibiotics pose a risk for subsequent colonization because these agents may eradicate the commensal flora of the host, thereby facilitating colonization with PPM.
The concept of colonisation resistance suggests a beneficial effect of the anaerobic flora in resisting colonisation by PPM along the digestive tract. SDD aims to selectively eliminate PPM and yeasts from the oropharyngeal cavity and gastrointestinal tract without disturbing the anaerobic flora.
The proposed benefits of SDD include the prevention of primary and secondary endogenous infections and the limitation of resistance development by eleminating the intestinal reservoir of gram-negative bacteria.
Since 1984 more than 30 randomized clinical trials and 8 mata-analyses on SDD in intensive care patients have been performed. Although most individual studies and all meta-analysesdemonstrated reductions in ventilator associated pneumonia (VAP), the beneficial effects on secondary outcomes were less evident. Only one single center study showed beneficial effect both on mortality and delvelopment of antibiotic resistance.
A point of concern is the possibility of emergence of antimicrobial resistance due to the excessive use of antibiotics. finally, four studies suggested that oropharyngeal decontamination (without systemic or intestinal prophylaxis) was as efficacious as the complete SDD regimen for preventing VAP.
|- Main changes (audit trail)|
|- RECORD||5-sep-2005 - 2-dec-2008|