Simplified Selective Digestive Tract Decontamination for the Prevention of Intensive Care Unit Acquired Infections (SDDICU)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01798537
First received: February 17, 2013
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

A simplified graded gut decontamination protocol combined with rigorous bi-weekly screening and appropriate bacterial prophylaxis, will lead to a 25% reduction in the acquisition of blood stream infections and to a 25% reduction in lower airway colonization with multi drug resistant organisms. There will be no concomitant rise in gram-positive or fungal infection or a surgency of new resistance patterns.


Condition Intervention Phase
Bacteremia Associated With Intravascular Line
Ventilator Associated Pneumonia
Bacteremia
Drug: Neomycin Colistin Nystatin Vancomycin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Simplified Selective Digestive Tract Decontamination for the Prevention of ICU Infections in the Setting of High-level Antibiotic Resistance

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Number of Intensive care acquired infections per 1000 device days [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    A simplified graded SDD protocol combined with rigorous bi-weekly screening and appropriate bacterial prophylaxis, will lead to a reduction in the acquisition of central venous line blood-stream infections and to a reduction in ventilator associated pneumonia. There will be no concomitant rise in gram-positive or fungal infection or a surgency of new resistance patterns.


Secondary Outcome Measures:
  • The effect of SDD on the morbidity and mortality from MDRO on israeli ICU patients. [ Time Frame: two years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The effect of SDD on bacteriological screening of Israeli ICU patients [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2400
Study Start Date: June 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neomycin Colistin Nystatin Vancomycin

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

Drug: Neomycin Colistin Nystatin Vancomycin
All participating study arm patients will receive SDD from admission to discharge
Other Names:
  • 375 mg Neomycin
  • 100 mg Colistin Sulphate
  • 1 million units Nystatin *
  • 250 mg Vancomycin *
No Intervention: Control
No SDD given for 1 year Screening performed as in intervention arm

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Expected to be in the ICU > 72 hours
  2. Has an enteral feeding tube and can receive enteral medication
  3. Has a tracheal tube

Exclusion Criteria:

  1. Pt. is moribund - not expected to survive > 28 days
  2. Pt. or legal representative refuse to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798537

Contacts
Contact: Yaron P Bar-Lavie, M.D. ++972-50-206-2027 y_barlavie@rambam.health.gov.il
Contact: Mical Paul, Prof. ++972-50-206-2140 m_paul@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 31096
Contact: Yaron P Bar-Lavie, M.D.    ++972-50-206-2027    y_barlavie@rambam.health.gov.il   
Contact: Mical Paul, Prof.    ++972-50-206-2140    m_paul@rambam.health.gov.il   
Principal Investigator: Yaron P Bar-Lavie, M.D.         
Principal Investigator: Mical Paul, Prof.         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Chair: Yaron P Bar-Lavie, M.D. Rambam Health Care Campus, Haifa, Israel
Principal Investigator: Mical Paul, Prof. Rambam Health Care Campus, Haifa, Israel
  More Information

Publications:
Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01798537     History of Changes
Other Study ID Numbers: 0401-12-RMB CTIL, NIHP Israel
Study First Received: February 17, 2013
Last Updated: February 25, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Bacteremia
Pneumonia, Ventilator-Associated
Bacterial Infections
Cross Infection
Infection
Inflammation
Lung Diseases
Lung Injury
Pathologic Processes
Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Sepsis
Systemic Inflammatory Response Syndrome
Ventilator-Induced Lung Injury
Colistin
Neomycin
Nystatin
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014