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

Saidel-Odes, Lisa; Polachek, Hana; Peled, Nechama; Riesenberg, Klaris; Schlaeffer, Francisc; Trabelsi, Yafa; Eskira, Seada; Yousef, Baha; Smolykov, Rozalia; Codish, Shlomi; Borer, Abraham

doi:10.1086/663206

Cited by 163 publications

(114 citation statements)

References 25 publications

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“…In the pre-transplant setting, small studies evaluating the role of selective digestive decontamination (SDD) with oral gentamicin with or without oral colistin have demonstrated a significant decline in CRKP carriage rates. 96,97 However, this strategy was not effective in preventing CRKP infections in HSCT recipients 98 and has also been associated with the development of colistin and gentamicin resistance. 97,99 The development of resistance to some of the only treatment options for CRE infections is a major concern and thus the use of SDD prior to SOT or HSCT cannot be routinely recommended.…”

Section: Prevention Of Cre Infection In Transplant and Hematologic Onmentioning

confidence: 99%

Carbapenem-resistant Enterobacteriaceae in special populations: Solid organ transplant recipients, stem cell transplant recipients, and patients with hematologic malignancies

2016

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Carbapenem-resistant Enterobacteriaceae (CRE) are a major global public health concern and pose a serious threat to immunocompromised hosts, particularly patients with hematologic malignancies and solid organ (SOT) and stem cell transplant recipients. In endemic areas, carbapenem-resistant Klebsiella pneumoniae infections occur in 1-18% of SOT recipients, and patients with hematologic malignancies represent 16-24% of all patients with CRE bacteremia. Mortality rates approaching 60% have been reported in these patient populations. Early diagnosis and rapid initiation of targeted therapy is critical in the management of immunocompromised hosts with CRE infections, as recommended empiric regimens are not active against CRE. Therapeutic options are limited by antibiotic-associated toxicities, interactions with immunosuppressive agents, and paucity of antibiotic options currently available. Prevention of CRE infection in these patients requires a multidisciplinary approach involving hospital epidemiology and antimicrobial stewardship. Large, multicenter studies are needed to develop risk-stratification tools to assist in guiding the management of these individuals.

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Section: Prevention Of Cre Infection In Transplant and Hematologic Onmentioning

confidence: 99%

Carbapenem-resistant Enterobacteriaceae in special populations: Solid organ transplant recipients, stem cell transplant recipients, and patients with hematologic malignancies

2016

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“…These findings raise the crucial problem of the unsatisfactory efficacy of the available treatments, the need for infection prevention in patients at risk who need to avoid contact with these pathogens, and an attempt to eradicate their colonization. In the last few years, the efficacy and safety of selective digestive decontamination (SDD) with non absorbable antibiotics for the eradication of CRE carriage was evaluated in populations with various underlying conditions 5,6,[13][14][15] (Table 2). The available data seem to show that SDD, in particular with oral gentamicin, may be in general a suitable option in CRKp carriers with a moderate risk of developing resistance to gentamicin (see Table 2), especially in persistent carriers during decontamination.…”

Section: Letters To the Editormentioning

confidence: 99%

“…Corrado Girmenia, 1 Claudio Viscoli, 2 Alfonso Piciocchi, 3 Laura Cudillo, 4 Stefano Botti, 5 Antonio Errico, 6 Loredana Sarmati, 7 Fabio Ciceri, 8 Franco Locatelli, 9 Maddalena Giannella, 10 Matteo Bassetti, 11 Carlo Tascini, 12 Letizia Lombardini, 6,13 Ignazio Majolino, 14 Claudio Farina, 15 Francesco Luzzaro, 16 Gian Maria Rossolini, [17][18][19] and …”

Section: F E R R a T A S T O R T I F O U N D A T I O Nunclassified

Management of carbapenem resistant Klebsiella pneumoniae infections in stem cell transplant recipients: an Italian multidisciplinary consensus statement

et al. 2015

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The increasing incidence of infections by carbapenemresistant enterobacteria (CRE), in particular carbapenemresistant Klebsiella pneumoniae (CRKp), is a significant public health challenge worldwide.1 The interim results of the last European survey on CRE (EuSCAPE project 2013) indicate that CRKp is endemic in Italy, and that this endemicity is mostly contributed to by strains producing KPC-type carbapenemases.CRKp infections are associated with high morbidity and mortality rates, particularly among Intensive Care Units (ICU) patients, recipients of solid organ transplants (SOT) and patients with hematological malignancies. 1-3The Gruppo Italiano Trapianto Midollo Osseo (GITMO) recently performed a retrospective study (2010)(2011)(2012)(2013) which involved 52 stem cell transplant (SCT) centers to assess the epidemiology and the prognostic factors of CRKp infections in autologous and allogeneic SCT.4 Cases of CRKp infection were reported in 53.4% of the centers and were documented in 0.4% of autologous and 2% of allogeneic SCTs. A CRKp colonization was followed by an infection in about 30% of cases. The infection-related mortality rate was 16% in autologous and 64.4% in allogeneic SCT. A pre-transplant CRKp infection and inadequate first-line treatment were independent factors associated with an increase in mortality in allogeneic SCT patients who developed a CRKp infection. Indeed, despite the administration of a first-line CRKp-targeted antibiotic therapy (CTAT) (see below), 55% of patients who received a CTAT still died. These data underscored the challenge regarding CRKp infections, particularly in the allogeneic-SCT setting, in terms of outcome and management of post-transplant complications, and also raised an issue about the eligibility for transplant among patients who got colonized or had developed a CRKp infection before transplant.Based on these original data and on the recent literature, a multidisciplinary group of experts from GITMO, the Italian Association of Clinical Microbiologists (Associazione Microbiologi Clinici Italiani; AMCLI), the Italian Society of Infectious and Tropical Diseases (Società Italiana Malattie Infettive e Tropicali; SIMIT), and the Italian National Transplant Center (Centro Nazionale Trapianti; CNT) was convened with the aim of providing consensus recommendations for the management of CRKp infection/colonization in autologous and allogeneic-SCT recipients.The Expert Panel (EP) included 17 specialists in hematology, infectious diseases, clinical microbiology and nursing, who were selected by virtue of their expertise in research and clinical practice of infections in SCT. The areas of major concern were defined by generating clinical key issues using the criterion of clinical relevance, i.e. impact on patient management and risk of inappropriateness, and recommendations were obtained according to a nominal group technique.The EP focused its discussion on four key-issues considered relevant for the present recommendations that are shown in Table 1.Detection of CRKp carriers b...

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“…On the contrary, SDD has been successfully used as an adjunct in controlling an outbreak with multi-resistant Enterobacteriaceae [18] and carbapenem-resistant Klebsiella pneumoniae [19]. Furthermore, SDD supplemented with vancomycin was associated with lower MRSA colonization [20][21][22] and lower respiratory tract infection rates [22] in MRSA endemic settings.…”

Section: Requirements For Justification Of Sdd and Sodmentioning

confidence: 99%

Antibiotic prophylaxis in the era of multidrug-resistant bacteria

Wittekamp

Bonten

2012

Expert Opinion on Investigational Drugs

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The prophylactic use of antibiotics can only be justified when clinical benefits on relevant patient outcomes, such as morbidity or mortality, cost-effectiveness, and absence of immediate emergence of antibiotic resistance have been unequivocally demonstrated. In some intensive care unit (ICU) patients, antibiotic prophylaxis is used as part of selective digestive tract decontamination (SDD) and selective oropharyngeal decontamination (SOD). Recent trials in ICUs with low levels of antibiotic resistance strongly suggest that both regimens reduce the incidence of ICU-acquired infections and improve patient survival. Naturally, the unique microbial ecology of such settings reduce generalizability of results. Therefore, the routine use of SOD and SDD remains highly controversial, especially in ICUs with higher levels of antibiotic resistance. Moreover, convincing evidence is still missing on several important aspects related to efficacy and safety. Despite numerous trials, effects of SDD and SOD on antibiotic resistance during and after decolonization treatment have still been insufficiently investigated, and existing results are contradicting. Furthermore, the effects of both regimens on the non-culturable part of the intestinal flora remain unknown. Finally, cost-effectiveness has not been thoroughly investigated, and prices of the antimicrobial agents that have been used have increased dramatically in recent years. In this review, important knowledge gaps that so far prevent the widespread use of SDD and SOD will be addressed.

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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

Cited by 163 publications

References 25 publications

Carbapenem-resistant Enterobacteriaceae in special populations: Solid organ transplant recipients, stem cell transplant recipients, and patients with hematologic malignancies

Carbapenem-resistant Enterobacteriaceae in special populations: Solid organ transplant recipients, stem cell transplant recipients, and patients with hematologic malignancies

Management of carbapenem resistant Klebsiella pneumoniae infections in stem cell transplant recipients: an Italian multidisciplinary consensus statement

Antibiotic prophylaxis in the era of multidrug-resistant bacteria

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