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SDDICUSimplified Selective Digestive Tract Decontamination for the Prevention of ICU Infections in the Setting of High-level Antibiotic Resistance

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Ce qui est testé

Neomycin Colistin Nystatin Vancomycin

Médicament
Qui peut participer

Pneumonie associée aux soins de santé+15

+ Infections bactériennes et mycoses

+ Infections bactériennes

À partir de 18 ans
+5 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude de prévention

Phase 2 & 3
Interventionnel
Date de début : juin 2013
Voir le détail du protocole

Résumé

Sponsor principalRambam Health Care Campus
Contacts de l'étudeYaron P Bar-Lavie, M.D.Voir plus de contacts
Dernière mise à jour : 26 février 2013
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juin 2013

Date à laquelle le premier participant a commencé l'étude.

Simplified Selective Digestive Tract Decontamination for the prevention of ICU infections in a setting of high-level antibiotic resistance Scientific Background: Aerobic gram-negative bacilli (AGNB), Gram-positive bacteria and fungi are responsible for hospital acquired infections. This problem is especially typical in intensive care units (ICUs) due to the complexity of disease and wide use of invasive procedures. The common use of empiric wide-range antibiotic therapy had lead to the development significant resistance of these pathogens and this group of bacteria was defined as Multi-Drug Resistant Organisms (MDRO). Among these bacteria the most important and virulent are: Carbapenem Resistant Enterobacteriaceae (CRE), Extended Spectrum Beta Lactamases (ESBL), Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin Resistant Enterococci (VRE) as well as Fluconazol resistant Candida. The main reservoir of these organisms is the intestinal tract, which raises the possibility that their primary eradication may lead to control of the MDRO epidemic. Selective Digestive tract Decontamination (SDD) has been studied extensively over the last 10-15 years and there is a body of evidence that shows that this method can reduce acquired infections, bacterial drug resistance and mortality in various ICU settings. It should be pointed out however that many of these studies were performed in units with a low prevalence of infection from MDROs and that they were never performed in units were CREs are endemic. According to the described protocols, SDD was performed as a combination of an a oral antibiotic paste - Selective Oropharyngeal Decontamination (SOD) together with enteral medication given through a gastric feeding tube, as well as a few days of prophylactic intra-venous treatment with an early generation cephalosporin. This treatment method did not become a standard of care - mostly due to the concern that new resistance will develop to the prescribed enteral antibiotics, or that there will be a rise in the prevalence of other enteral infections as VRE, Clostridium difficile or MRSA acquired infections. Despite evidence that during the SDD treatment period there was actually a reduction of drug resistance, the Center for Disease Control and prevention (CDC) and the protocols of the surviving sepsis campaign do not recommend SDD as a means of coping with the MDRO epidemic. In published SDD protocols there was a use of wide-spectrum antibiotics that covered the range of gram-positive, gram-negative bacteria and fungi, without correlation to the results of primary screening in these patients. Even though this approach did not lead to a rise in bacterial resistance, it raised enough anxiety and resistance within the caregivers to prevent its penetration to daily use. The endemic spread of CRE infection at Rambam Medical Center has lead us to focus on these pathogens in our SDD program, while performing rigorous bi-weekly screening for all bacteria. We gave enteral antibiotic treatment (Neomycin + Polymixin E) targeting AGNB, and only if the primary screening found MRSA or Fungi, did we prescribe enteral preventive treatment against them (Vancomycin or Nystatin). Therefore, a prospective study was performed during 2011 at Rambam department of critical care medicine, on the influence of a simplified SDD protocol on the acquisition of AGNB infection in the ICU. The results show a significant reduction in blood stream infections and a change in the epidemiology of colonization of the respiratory tract - from resistant to sensitive bacteria. There was a concomitant reduction in the use of MDRO- targeted antibiotics. The proposed multi-center study is based on this successful experience and will focus on the influence of a simplified SDD protocol on colonization and infection with MDROs in israeli ICUs where CREs are endemic.

NCT01798537
Sponsor principalRambam Health Care Campus
Contacts de l'étudeYaron P Bar-Lavie, M.D.Voir plus de contacts
Dernière mise à jour : 26 février 2013
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

2400 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Prévention

Cette étude cherche à prévenir l'apparition d'une maladie ou d'un trouble chez des personnes qui ne l'ont pas encore développé. Elles concernent souvent des personnes à risque et testent des vaccins, des changements de mode de vie ou des traitements préventifs.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Pneumonie associée aux soins de santéInfections bactériennes et mycosesInfections bactériennesInfection CroiséeMaladie IatrogèneInfectionsInflammationMaladies pulmonairesProcessus pathologiquesPneumonieMaladies des voies respiratoiresInfections des voies respiratoiresConditions pathologiques, signes et symptômesSyndrome de Réponse Inflammatoire SystémiqueSepsisAttributs de la maladieBactériémiePneumonie associée au ventilateur

Critères

3 critères d'inclusion nécessaires pour participer
Expected to be in the ICU > 72 hours

Has a tracheal tube

Has an enteral feeding tube and can receive enteral medication

2 critères d'exclusion empêchent la participation
Pt. is moribund - not expected to survive > 28 days

Pt. or legal representative refuse to participate

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
All participating study arm patients will receive SDD from admission to discharge according to the following plan: ENTERAL MEDICATION (via feeding tube) x 4 times daily: 375 mg Neomycin 100 mg Colistin Sulphate 1 million units Nystatin * 250 mg Vancomycin * Nystatin will be prescribed only if there is a positive sputum or urine culture for yeast or candida Vancomycin will be prescribed only in case of a positive screen or culture for MRSA

Groupe II

Pas d'intervention
No SDD given for 1 year Screening performed as in intervention arm

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Rambam Health Care Campus

Haifa, IsraelOuvrir Rambam Health Care Campus dans Google Maps
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