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A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella pneumoniae Carriage

Published online by Cambridge University Press:  02 January 2015

Lisa Saidel-Odes ,
Hana Polachek ,
Nehama Peled ,
Klaris Riesenberg ,
Francisc Schlaeffer ,
Yafa Trabelsi ,
Seada Eskira ,
Baha Yousef ,
Rozalia Smolykov  and
Shlomi Codish
...Show all authors
Lisa Saidel-Odes*
Affiliation:
Infectious Diseases Institute, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel Internal Medicine B, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Hana Polachek
Affiliation:
Hospital Pharmacy, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Nehama Peled
Affiliation:
Clinical Microbiology Laboratory, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Klaris Riesenberg
Affiliation:
Infectious Diseases Institute, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Francisc Schlaeffer
Affiliation:
Infectious Diseases Institute, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Yafa Trabelsi
Affiliation:
Internal Medicine B, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Seada Eskira
Affiliation:
Infection Control and Hospital Epidemiology Unit, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Baha Yousef
Affiliation:
Internal Medicine B, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Rozalia Smolykov
Affiliation:
Infectious Diseases Institute, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Shlomi Codish
Affiliation:
Hospital Administration, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Abraham Borer
Affiliation:
Infection Control and Hospital Epidemiology Unit, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel
*
Infectious Diseases Institute, Soroka University Medical Center, P.O. Box 151, Beer-Sheva 84101, Israel ([email protected])
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Abstract

Objective.

To assess the effectiveness of selective digestive decontamination (SDD) for eradicating carbapenem-resistant Klebsiella pneumoniae (CRKP) oropharyngeal and gastrointestinal carriage.

Design.

A randomized, double-blind, placebo-controlled trial with 7 weeks of follow-up per patient.

Setting.

A 1,000-bed tertiary-care university hospital.

Patients.

Adults with CRKP-positive rectal swab cultures.

Methods.

Patients were blindly randomized (1:1) over a 20-month period. The SDD arm received oral gentamicin and polymyxin E gel (0.5 g 4 times per day) and oral solutions of gentamicin (80 mg 4 times per day) and polymyxin E (1 × 106 units 4 times per day for 7 days). The placebo arm received oral placebo gel 4 times per day and 2 placebo oral solutions 4 times per day for 7 days. Strict contact precautions were applied. Samples obtained from the throat, groin, and urine were also cultured.

Results.

Forty patients (mean age ± standard deviation, 71 ± 16 years; 65% male) were included. At screening, greater than or equal to 30% of oropharyngeal, greater than or equal to 60% of skin, and greater than or equal to 35% of urine cultures yielded CRKP isolates. All throat cultures became negative in the SDD arm after 3 days (P< .0001). The percentages of rectal cultures that were positive for CRKP were significandy reduced at 2 weeks. At that time, 16.1% of rectal cultures in the placebo arm and 61.1% in the SDD arm were negative (odds ratio, 0.13; 95% confidence interval, 0.02–0.74; P<.0016). A difference between the percentages in the 2 arms was still maintained at 6 weeks (33.3% vs 58.5%). Groin colonization prevalence did not change in either arm, and the prevalence of urine colonization increased in the placebo arm.

Conclusions.

This SDD regimen could be a suitable decolonization therapy for selected patients colonized with CRKP, such as transplant recipients or immunocompromised patients pending chemotherapy and patients who require major intestinal or oropharyngeal surgery. Moreover, in outbreaks caused by CRKP infections that are uncontrolled by routine infection control measures, SDD could provide additional infection containment.

Infect Control Hosp Epidemiol 2012;33(1):14-19

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 33 , Issue 1 , January 2012 , pp. 14 - 19
Copyright
Copyright © The Society for Healthcare Epidemiology of America 2012

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References

1. Kochar, S, Sheard, T, Sharma, R, et al. Success of an infection control program to reduce the spread of carbapenem-resistant Klebsiella pneumoniae . Infect Control Hosp Epidemiol 2009;30:447–452.Google Scholar
2. Centers for Disease Control and Prevention (CDC). Guidance for control of infections with carbapenem-resistant or carbapenem-producing Enterobacteriaceae in acute care facilities. MMWR Morb Mortal Wkly Rep 2009;58:256–260.Google Scholar
3. Patel, G, Huprikar, S, Factor, SH, Jenkins, SG, Calfee, DP. Outcomes of carbapenem-resistant Klebsiella pneumoniae infection and the impact of antimicrobial and adjunctive therapies. Infect Control Hosp Epidemiol 2008;29:1099–1106.Google Scholar
4. Calfee, D, Jenkins, SG. Use of active surveillance cultures to detect asymptomatic colonization with carbapenem-resistant Klebsiella pneumoniae in intensive care unit patients. Infect Control Hosp Epidemiol 2008;29:966–968.CrossRefGoogle ScholarPubMed
5. Borer, A, Saidel-Odes, L, Reisenberg, K, et al. Attributable mortality of carbapenem resistant Klebsiella pneumoniae bacteremia. Infect Control Hosp Epidemiol 2009;30:972–976.CrossRefGoogle ScholarPubMed
6. Mouloudi, E, Protonotariou, E, Zagorianou, A, et al. Bloodstream infections caused by metallo-β-lactamase/Klebsiella pneumoniae carbapenemase-producing K. pneumoniae among intensive care unit patients in Greece: risk factors for infection and impact of type of resistance on outcomes. Infect Control Hosp Epidemiol 2010;31:1250–1256.Google Scholar
7. Schwaber, MJ, Klarfeld-Lidji, S, Navon-Venezia, S, Schwartz, D, Leavitt, A, Carmeli, Y. Predictors of carbapenem-resistant Klebsiella pneumoniae acquisition among hospitalized adults and effect of acquisition on mortality. Antimicrob Agents Chemother 2008;52:1028–1033.Google Scholar
8. Silvestri, L, Kerr, S, Gullo, A. Prevention of infection using selective decontamination of the digestive tract. In: van Saene, HKF, Silvestri, L, de la Cal, MA, eds. Infection Control in the Intensive Care Unit. 2nd ed. Milan: Springer, 2005:297–312.CrossRefGoogle ScholarPubMed
9. D'Amico, R, Pifferi, S, Leonetti, C, Torri, V, Tinazzi, A, Liberati, A. Effectiveness of antibiotic prophylaxis in critically ill adult patients: systematic review of randomised controlled trials. BMJ 1998;316:1275–1285.Google Scholar
10. Haas, LEM, Schultz, MJ. Selective decontamination of the digestive tract reduces pneumonia and mortality. Crit Care Res Pract 2010;2010:501031. Published October 7, 2010.Google Scholar
11. Ulrich, C, Harinck-de Weerd, JE, Bakker, NC, Jacz, K, Doornbos, L, de Ridder, VA. Selective decontamination of the digestive tract with norfloxacin in the prevention of ICU-acquired infections: a prospective randomized study. Intensive Care Med 1989;15:424–431.Google Scholar
12. Rocha, LA, Martin, MJ, Pita, S, et al. Prevention of nosocomial infections in critically ill patients by selective decontamination of the digestive tract: a randomized, double blind, placebo-controlled study. Intensive Care Med 1992;18:398–404.Google Scholar
13. Krueger, WA, Lenhart, FP, Neeser, G, et al. Influence of combined intravenous and topical antibiotic prophylaxis on the incidence of infections, organ dysfunctions, and mortality in critically ill surgical patients: a prospective, stratified, randomized, double-blind, placebo-controlled clinical trial. Am J Respir Crit Care Med 2002;166:1029–1037.Google Scholar
14. Nathens, AB, Marshall, JC. Selective decontamination of the digestive tract in surgical patients: a systematic review of the evidence. Arch Surg 1999;134:170–176.Google Scholar
15. Oostdijk, EA, de Smet, AM, Kesecioglu, J, et al. The role of intestinal colonization with gram-negative bacteria as a source for intensive care unit-acquired bacteremia. Crit Care Med 2011;39:961–966.Google Scholar
16. de Jonge, E, Schultz, MJ, Spanjaard, L, et al. Effects of selective decontamination of digestive tract on mortality and acquisition of resistant bacteria in intensive care: a randomised controlled trial. Lancet 2003;362:1011–1016.CrossRefGoogle ScholarPubMed
17. de Smet, AM, Kluytmans, JA, Cooper, BS, et al. Decontamination of the digestive tract and oropharynx in ICU patients. N Engl J Med 2009;360:20–31.Google Scholar
18. Brun-Buisson, C, Legrand, P, Rauss, A, et al. Intestinal decontamination for control of nosocomial multiresistant gram-negative bacilli: study of an outbreak in an intensive care unit. Ann Intern Med 1989;110:873–881.CrossRefGoogle Scholar
19. Taylor, ME, Oppenheim, BA. Selective decontamination of the gastrointestinal tract as an infection control measure. J Hosp Infect 1991;17:271–278.Google Scholar
20. Hammond, JM, Potgieter, PD, Saunders, GL, Forder, AA. Double-blind study of selective decontamination of the digestive tract in intensive care. Lancet 1992;340:5–9.Google Scholar
21. Hebert, C, Robicsek, A. Decolonization therapy in infection control. Curr Opin Infect Dis 2010;23:340–345.Google Scholar
22. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing: 20th Informational Supplement. CLSI document. Wayne, PA: Clinical and Laboratory Standards Institute, 2010. M100-S20.Google Scholar
23. Anderson, KF, Lonsway, DR, Rasheed, JK, et al. Evaluation of methods to identify the Klebsiella pneumoniae carbapenase in Enterobactereaceae. J Clin Microbiol 2007;45:2723–2725.Google Scholar
24. European Committee on Antimicrobial Susceptibility Testing. Clinical breakpoint tables vl.3, 2011. http://www.eucast.org/clinicalbreakpoints/. Published January 5, 2011.Google Scholar
25. Borer, A, Gilad, J, Porat, N, et al. Impact of 4% chlorhexidine whole-body washing on multidrug-resistant Acinetobacter baumannii skin colonisation among patients in a medical intensive care unit. J Hosp Infect 2007;67:149–155.Google Scholar
26. Vernon, MO, Hayden, MK, Trick, WE, Hayes, RA, Blom, DW, Weinstein, RA. The effectiveness of source control to reduce the bioburden of vancomicin-resistant Enterococci . Arch Intern Med 2006;166:306–312.Google Scholar
27. Zuckerman, T, Benyamini, N, Sprecher, H, et al. SCT in patients with carbapenem resistant Klebsiella pneumoniae: a single center experience with oral gentamicin for the eradication of carrier state. Bone Marrow Transplant 2011;46:1126–1130.Google Scholar
28. Reilly, NJ, Nunn, AJ, Pollock, K. Selective decontamination of the digestive tract: the role of the pharmacist. In: van Saene, HKF, Silvestri, L, de la Cal, MA, eds. Infection Control in the Intensive Care Unit. 2nd ed. Milan: Springer, 2005:575–592.Google Scholar