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

NCT01798537 | Unknown Phase 2 DMC

• 2 other identifiers: 0401-12-RMB CTILNIHP Israel
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacteremia Associated With Intravascular Line; Ventilator Associated Pneumonia; Bacteremia

Outcome Measures

Primary Outcomes (1)

• Number of Intensive care acquired infections per 1000 device days

  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.

  two years

Secondary Outcomes (1)

• The effect of SDD on the morbidity and mortality from MDRO on israeli ICU patients.

  two years

Other Outcomes (1)

• The effect of SDD on bacteriological screening of Israeli ICU patients

  two years

Study Arms (2)

Neomycin Colistin Nystatin Vancomycin

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Neomycin Colistin Nystatin Vancomycin DRUG

All participating study arm patients will receive SDD from admission to discharge

Also known as: 375 mg Neomycin, 100 mg Colistin Sulphate, 1 million units Nystatin *, 250 mg Vancomycin *

Neomycin Colistin Nystatin Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expected to be in the ICU \> 72 hours
• Has an enteral feeding tube and can receive enteral medication
• Has a tracheal tube

You may not qualify if:

• Pt. is moribund - not expected to survive \> 28 days
• Pt. or legal representative refuse to participate

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Related Publications (6)

• de Jonge E, Schultz MJ, Spanjaard L, Bossuyt PM, Vroom MB, Dankert J, Kesecioglu J. Effects of selective decontamination of digestive tract on mortality and acquisition of resistant bacteria in intensive care: a randomised controlled trial. Lancet. 2003 Sep 27;362(9389):1011-6. doi: 10.1016/S0140-6736(03)14409-1.

  PMID: 14522530 BACKGROUND

• de Smet AM, Kluytmans JA, Cooper BS, Mascini EM, Benus RF, van der Werf TS, van der Hoeven JG, Pickkers P, Bogaers-Hofman D, van der Meer NJ, Bernards AT, Kuijper EJ, Joore JC, Leverstein-van Hall MA, Bindels AJ, Jansz AR, Wesselink RM, de Jongh BM, Dennesen PJ, van Asselt GJ, te Velde LF, Frenay IH, Kaasjager K, Bosch FH, van Iterson M, Thijsen SF, Kluge GH, Pauw W, de Vries JW, Kaan JA, Arends JP, Aarts LP, Sturm PD, Harinck HI, Voss A, Uijtendaal EV, Blok HE, Thieme Groen ES, Pouw ME, Kalkman CJ, Bonten MJ. Decontamination of the digestive tract and oropharynx in ICU patients. N Engl J Med. 2009 Jan 1;360(1):20-31. doi: 10.1056/NEJMoa0800394.

  PMID: 19118302 BACKGROUND

• de Smet AM, Kluytmans JA, Blok HE, Mascini EM, Benus RF, Bernards AT, Kuijper EJ, Leverstein-van Hall MA, Jansz AR, de Jongh BM, van Asselt GJ, Frenay IH, Thijsen SF, Conijn SN, Kaan JA, Arends JP, Sturm PD, Bootsma MC, Bonten MJ. Selective digestive tract decontamination and selective oropharyngeal decontamination and antibiotic resistance in patients in intensive-care units: an open-label, clustered group-randomised, crossover study. Lancet Infect Dis. 2011 May;11(5):372-80. doi: 10.1016/S1473-3099(11)70035-4. Epub 2011 Mar 21.

  PMID: 21420908 BACKGROUND

• Schultz MJ, Haas LE. Antibiotics or probiotics as preventive measures against ventilator-associated pneumonia: a literature review. Crit Care. 2011;15(1):R18. doi: 10.1186/cc9963. Epub 2011 Jan 13.

  PMID: 21232110 BACKGROUND

• van Saene HK, Petros AJ, Ramsay G, Baxby D. All great truths are iconoclastic: selective decontamination of the digestive tract moves from heresy to level 1 truth. Intensive Care Med. 2003 May;29(5):677-90. doi: 10.1007/s00134-003-1722-2. Epub 2003 Apr 10.

  PMID: 12687326 BACKGROUND

• Silvestri L, van Saene HK, Milanese M, Gregori D, Gullo A. Selective decontamination of the digestive tract reduces bacterial bloodstream infection and mortality in critically ill patients. Systematic review of randomized, controlled trials. J Hosp Infect. 2007 Mar;65(3):187-203. doi: 10.1016/j.jhin.2006.10.014. Epub 2007 Jan 22.

  PMID: 17244516 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Bacteremia

Interventions

Neomycin; Colistin; Vancomycin

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates; Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Glycopeptides; Glycoconjugates

Study Officials

• Yaron P Bar-Lavie, M.D.

  Rambam Health Care Campus, Haifa, Israel

  STUDY CHAIR

• Mical Paul, Prof.

  Rambam Health Care Campus, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaron P Bar-Lavie, M.D.

CONTACT

++972-50-206-2027; y_barlavie@rambam.health.gov.il

Mical Paul, Prof.

CONTACT

++972-50-206-2140; m_paul@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2013
• First Posted: February 26, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

IL (1)