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Article ; Online: Higher prevalence of CTX-M-27-producing Escherichia coli belonging to ST131 clade C1 among residents of two long-term care facilities in Southern Spain.

López-Cerero, Lorena / Salamanca, Elena / Delgado-Valverde, Mercedes / Rodríguez-Martínez, José Manuel / Rodríguez-Baño, Jesús / Pascual, Álvaro

European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology

2021 Volume 41, Issue 2, Page(s) 335–338

Abstract: Recently, the emergence of an international lineage of the CTX-M-27-producing clade C1 of Escherichia coli ST131 is being observed. The aim is to see if this strain has also been introduced in our area. Twenty-eight (33%) out of 86 individuals from two ... ...

Abstract	Recently, the emergence of an international lineage of the CTX-M-27-producing clade C1 of Escherichia coli ST131 is being observed. The aim is to see if this strain has also been introduced in our area. Twenty-eight (33%) out of 86 individuals from two LTCFs in Seville were found to be colonized with fluoroquinolone-resistant E. coli ST131 and 46% isolates were ESBL/pAmpC producers. C1 isolates were more common than C2 and more frequently produced bla
MeSH term(s)	Anti-Bacterial Agents ; Escherichia coli/enzymology ; Escherichia coli/genetics ; Escherichia coli/isolation & purification ; Escherichia coli Infections/epidemiology ; Escherichia coli Infections/microbiology ; Escherichia coli Proteins/genetics ; Escherichia coli Proteins/metabolism ; Humans ; Long-Term Care ; Polymorphism, Single Nucleotide ; Prevalence ; Spain/epidemiology ; beta-Lactamases/genetics ; beta-Lactamases/metabolism
Chemical Substances	Anti-Bacterial Agents ; Escherichia coli Proteins ; CTX-M-27, E coli (EC 3.5.2.-) ; beta-Lactamases (EC 3.5.2.6)
Language	English
Publishing date	2021-11-17
Publishing country	Germany
Document type	Journal Article
ZDB-ID	603155-9
ISSN	1435-4373 ; 0934-9723 ; 0722-2211
ISSN (online)	1435-4373
ISSN	0934-9723 ; 0722-2211
DOI	10.1007/s10096-021-04380-6
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Article ; Online: Randomised, open-label, non-inferiority clinical trial on the efficacy and safety of a 7-day vs 14-day course of antibiotic treatment for uncomplicated enterococcal bacteraemia: the INTENSE trial protocol.

Maldonado, Natalia / Rosso-Fernández, Clara M / Portillo-Calderón, Inés / Borreguero Borreguero, Irene / Tristán-Clavijo, Enriqueta / Palacios-Baena, Zaira R / Salamanca, Elena / Fernández-Cuenca, Felipe / De-Cueto, Marina / Stolz-Larrieu, Emilio / Rodriguez-Baño, Jesús / López-Cortés, Luis Eduardo

BMJ open

2023 Volume 13, Issue 9, Page(s) e075699

Abstract: Introduction: Enterococcus: Methods: The INTENSE study is a multicentre, open-label, randomised, pragmatic, phase-IV clinical trial to demonstrate the non-inferiority of a 7-day vs 14-day course for the treatment of uncomplicated enterococcal ... ...

Abstract	Introduction: Enterococcus Methods: The INTENSE study is a multicentre, open-label, randomised, pragmatic, phase-IV clinical trial to demonstrate the non-inferiority of a 7-day vs 14-day course for the treatment of uncomplicated enterococcal bacteraemia and incorporating the early switching to oral antibiotics when feasible. The primary efficacy endpoint is the clinical cure at day 30±2 after the end of the treatment. Secondary endpoints will include the rate of relapse or infective endocarditis, length of stay, duration of intravenous therapy, Analysis: The difference in proportions with one-sided 95% CIs will be calculated for the clinical cure rate using the control group as reference. For secondary categorical endpoints, a similar analysis will be performed and Mann-Whitney U-test will be used to compare median values of quantitative variables. A superiority analysis applying the response adjusted for days of antibiotic risk will be performed if there were incidents in recruitment; will allow obtaining results with 194 patients recruited. Ethics and dissemination: The study has obtained the authorisation from the Spanish Regulatory Authority, the approval of the ethics committee and the agreement of the directors of each centre. Data will be published in peer-reviewed journals. Trial registration number: NCT05394298.
MeSH term(s)	Humans ; Bacterial Infections ; Bacteremia/drug therapy ; Anti-Bacterial Agents/adverse effects ; Endocarditis ; Control Groups ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic ; Clinical Trials, Phase IV as Topic
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2023-09-06
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2023-075699
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Article ; Online: Increased Blood Monocytic Myeloid Derived Suppressor Cells but Low Regulatory T Lymphocytes in Patients with Mild COVID-19.

Jiménez-Cortegana, Carlos / Liró, Julia / Palazón-Carrión, Natalia / Salamanca, Elena / Sojo-Dorado, Jesús / de la Cruz-Merino, Luis / Pascual, Álvaro / Rodríguez-Baño, Jesús / Sánchez-Margalet, Víctor

Viral immunology

2021 Volume 34, Issue 9, Page(s) 639–645

Abstract: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection may produce a systemic disease, the coronavirus disease-19 (COVID-19), with high morbidity and mortality. Even though we do not fully understand the interaction of innate and ... ...

Abstract	The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection may produce a systemic disease, the coronavirus disease-19 (COVID-19), with high morbidity and mortality. Even though we do not fully understand the interaction of innate and adaptive immunity in the control and complications of the viral infection, it is well recognized that SARS-CoV-2 induces an immunodepression that impairs the elimination of the virus and favors its rapid dissemination in the organism. Even less is known about the possible participation of inhibitory cells of the innate immune system, such as the myeloid-derived suppressor cells (MDSCs), or the adaptive immune system, such as the T regulatory cells (Tregs). That is why we aimed to study blood levels of MDSCs, as well as lymphocyte subpopulations, including Tregs, and activated (OX-40+) and inhibited (PD-1) T lymphocytes in patients with mild COVID-19 in comparison with data obtained from control donors. We have found that 20 hospitalized patients with COVID-19 and no health history of immunosuppression had a significant increase in the number of peripheral monocytic MDSCs (M-MDSC), but a decrease in Tregs, as well as an increase in the number of inhibited or exhausted T cells, whereas the number of activated T cells was significantly decreased compared with that from 20 healthy controls. Moreover, there was a significant negative correlation (
MeSH term(s)	Aged ; COVID-19/blood ; COVID-19/classification ; COVID-19/immunology ; Female ; Humans ; Lymphocyte Activation ; Lymphocyte Count/methods ; Lymphocyte Subsets ; Male ; Middle Aged ; Myeloid-Derived Suppressor Cells/immunology ; SARS-CoV-2/immunology ; SARS-CoV-2/pathogenicity ; T-Lymphocytes, Regulatory/immunology
Language	English
Publishing date	2021-09-16
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639075-4
ISSN	1557-8976 ; 0882-8245
ISSN (online)	1557-8976
ISSN	0882-8245
DOI	10.1089/vim.2021.0044
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Article ; Online: Circulating myeloid-derived suppressor cells may be a useful biomarker in the follow-up of unvaccinated COVID-19 patients after hospitalization.

Jiménez-Cortegana, Carlos / Salamanca, Elena / Palazón-Carrión, Natalia / Sánchez-Jiménez, Flora / Pérez-Pérez, Antonio / Vilariño-García, Teresa / Fuentes, Sandra / Martín, Salomón / Jiménez, Marta / Galván, Raquel / Rodríguez-Chacón, Carmen / Sánchez-Mora, Catalina / Moreno-Mellado, Elisa / Gutiérrez-Gutiérrez, Belén / Álvarez, Nerissa / Sosa, Alberto / Garnacho-Montero, José / de la Cruz-Merino, Luis / Rodríguez-Baño, Jesús /

Sánchez-Margalet, Víctor

Frontiers in immunology

2023 Volume 14, Page(s) 1266659

Abstract: SARS-CoV-2 infection is the cause of the disease named COVID-19, a major public health challenge worldwide. Differences in the severity, complications and outcomes of the COVID-19 are intriguing and, patients with similar baseline clinical conditions may ...

Abstract	SARS-CoV-2 infection is the cause of the disease named COVID-19, a major public health challenge worldwide. Differences in the severity, complications and outcomes of the COVID-19 are intriguing and, patients with similar baseline clinical conditions may have very different evolution. Myeloid-derived suppressor cells (MDSCs) have been previously found to be recruited by the SARS-CoV-2 infection and may be a marker of clinical evolution in these patients. We have studied 90 consecutive patients admitted in the hospital before the vaccination program started in the general population, to measure MDSCs and lymphocyte subpopulations at admission and one week after to assess the possible association with unfavorable outcomes (dead or Intensive Care Unit admission). We analyzed MDSCs and lymphocyte subpopulations by flow cytometry. In the 72 patients discharged from the hospital, there were significant decreases in the monocytic and total MDSC populations measured in peripheral blood after one week but, most importantly, the number of MDSCs (total and both monocytic and granulocytic subsets) were much higher in the 18 patients with unfavorable outcome. In conclusion, the number of circulating MDSCs may be a good marker of evolution in the follow-up of unvaccinated patients admitted in the hospital with the diagnosis of COVID-19.
MeSH term(s)	Humans ; Myeloid-Derived Suppressor Cells ; Follow-Up Studies ; COVID-19 ; SARS-CoV-2 ; Biomarkers ; Hospitalization
Chemical Substances	Biomarkers
Language	English
Publishing date	2023-11-14
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2023.1266659
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Article ; Online: Development and validation of a laboratory-based risk score to predict the occurrence of critical illness in hospitalized patients with COVID-19.

Martin, Salomon / Fuentes, Sandra / Sanchez, Catalina / Jimenez, Marta / Navarro, Carmen / Perez, Helena / Salamanca, Elena / Santotoribio, Jose D / Bobillo, Joaquín / Giron, Jose A / Gonzalez, Javier / Garrido, Jose M / Liro, Julia / Guerrero, Juan M / Sanchez-Pozo, Maria Cristina / Sanchez-Margalet, Victor / Leon-Justel, Antonio

Scandinavian journal of clinical and laboratory investigation

2021 Volume 81, Issue 4, Page(s) 282–289

Abstract: Background: Early identification of patients with COVID-19 who may develop critical illness is of great importance.: Methods: In this study a retrospective cohort of 264 COVID-19 cases admitted at Macarena University was used for development and ... ...

Abstract	Background: Early identification of patients with COVID-19 who may develop critical illness is of great importance. Methods: In this study a retrospective cohort of 264 COVID-19 cases admitted at Macarena University was used for development and internal validation of a risk score to predict the occurrence of critical illness in hospitalized patients with COVID-19. Backward stepwise logistic regression was used to derive the model, including clinical and laboratory variables predictive of critical illness. Internal validation of the final model used bootstrapped samples and the model scoring derived from the coefficients. External validation was performed in a cohort of 154 cases admitted at Valme and Virgen del Rocio University Hospital. Results: A total of 62 (23.5%) patients developed a critical illness during their hospitalization stay, 21 (8.0%) patients needed invasive ventilation, 34 (12.9%) were admitted at the ICU and the overall mortality was of 14.8% (39 cases). 5 variables were included in the final model: age >59.5 years (OR: 3.11;95%CI 1.39-6.97), abnormal CRP results (OR: 5.76;95%CI 2.32-14.30), abnormal lymphocytes count (OR: 3.252;95%CI 1.56-6.77), abnormal CK results (OR: 3.38;95%CI 1.59-7.20) and abnormal creatinine (OR: 3.30;95%CI 1.42-7.68). The AUC of this model was 0.850 with sensitivity of 65% and specificity of 87% and the IDI and NRI were 0.1744 and 0.2785, respectively. The validation indicated a good discrimination for the external population. Conclusions: Biomarkers add prognostic information in COVID-19 patients. Our risk-score provides an easy to use tool to identify patients who are likely to develop critical illness during their hospital stay.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Biomarkers/blood ; C-Reactive Protein/analysis ; COVID-19/etiology ; COVID-19/mortality ; COVID-19/therapy ; Creatine Kinase/blood ; Creatinine/blood ; Critical Illness ; Female ; Hospitalization ; Humans ; Laboratories ; Lymphocyte Count ; Male ; Middle Aged ; Respiration, Artificial ; Retrospective Studies ; Risk Assessment ; Sensitivity and Specificity ; Young Adult
Chemical Substances	Biomarkers ; C-Reactive Protein (9007-41-4) ; Creatinine (AYI8EX34EU) ; Creatine Kinase (EC 2.7.3.2)
Language	English
Publishing date	2021-05-11
Publishing country	England
Document type	Journal Article ; Validation Study
ZDB-ID	3150-1
ISSN	1502-7686 ; 0036-5513
ISSN (online)	1502-7686
ISSN	0036-5513
DOI	10.1080/00365513.2020.1847313
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Article ; Online: Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant

Marín-Candón, Alicia / Rosso-Fernández, Clara M / Bustos de Godoy, Natalia / López-Cerero, Lorena / Gutiérrez-Gutiérrez, Belén / López-Cortés, Luis Eduardo / Barrera Pulido, Lydia / Borreguero Borreguero, Irene / León, María José / Merino, Vicente / Camean-Fernández, Manuel / Retamar, Pilar / Salamanca, Elena / Pascual, Alvaro / Rodriguez-Baño, Jesús

BMJ open

2021 Volume 11, Issue 9, Page(s) e049481

Abstract: Introduction: Alternatives to carbapenems are needed in the treatment of third-generation cephalosporin-resistant : Methods and analysis: Multicentre, open-label, randomised, controlled, pragmatic phase 3 trial. Patients with bacteraemia due to 3GCR- ... ...

Abstract	Introduction: Alternatives to carbapenems are needed in the treatment of third-generation cephalosporin-resistant Methods and analysis: Multicentre, open-label, randomised, controlled, pragmatic phase 3 trial. Patients with bacteraemia due to 3GCR-E will be randomised to receive intravenously temocillin (2 g three times a day) or carbapenem (meropenem 1 g three times a day or ertapenem 1 g once daily). The primary endpoint will be clinical success 7-10 days after end of treatment with no recurrence or death at day 28. Adverse events will be collected; serum levels of temocillin will be investigated in a subset of patients. For a 10% non-inferiority margin, 334 patients will be included (167 in each study arm). For the primary analysis, the absolute difference with one-sided 95% CI in the proportion of patients reaching the primary endpoint will be compared in the modified intention-to-treat population. Ethics and dissemination: The study started after approval of the Spanish Regulatory Agency and the reference institutional review board. Data will be published in peer-reviewed journals. Trial registration number: NCT04478721.
MeSH term(s)	Bacteremia/drug therapy ; Cephalosporins/pharmacology ; Clinical Trials, Phase III as Topic ; Enterobacteriaceae/drug effects ; Humans ; Meropenem/therapeutic use ; Multicenter Studies as Topic ; Penicillins/therapeutic use ; Pragmatic Clinical Trials as Topic ; Randomized Controlled Trials as Topic
Chemical Substances	Cephalosporins ; Penicillins ; temocillin (03QB156W6I) ; Meropenem (FV9J3JU8B1)
Language	English
Publishing date	2021-09-27
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-049481
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Article ; Online: Populations of extended-spectrum β-lactamase-producing Escherichia coli and Klebsiella pneumoniae are different in human-polluted environment and food items: a multicentre European study.

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

2021 Volume 28, Issue 3, Page(s) 447.e7–447.e14

Abstract: Objectives: To assess the extent to which food items are a source of extended-spectrum β-lactamase (ESBL) -producing Escherichia coli (ESBL-Ec) and ESBL-producing Klebsiella pneumoniae (ESBL-Kp) for humans in five European cities.: Methods: We ... ...

Abstract	Objectives: To assess the extent to which food items are a source of extended-spectrum β-lactamase (ESBL) -producing Escherichia coli (ESBL-Ec) and ESBL-producing Klebsiella pneumoniae (ESBL-Kp) for humans in five European cities. Methods: We sampled 122 human polluted (hp)-environments (sewers and polluted rivers, as a proxy of human contamination) and 714 food items in Besançon (France), Geneva (Switzerland), Sevilla (Spain), Tübingen (Germany) and Utrecht (The Netherlands). A total of 254 ESBL-Ec and 39 ESBL-Kp isolates were cultured. All genomes were fully sequenced to compare their sequence types (ST) and core genomes, along with the distribution of bla Results: Sequence data revealed that ESBL-Ec and ESBL-Kp isolates from hp-environments were genetically different from those contaminating food items. ESBL-Ec ST131 was widespread in the hp-environment (21.5% of the isolates) but absent from the food items tested. ESBL-Ec ST10 was in similar proportions in hp-environments and food items (15 and 10 isolates, respectively) but mostly carried reservoir-specific bla Conclusions: We found a very limited connection between ESBL-Ec and ESBL-Kp populations retrieved in food items and from hp-environments and bla
MeSH term(s)	Anti-Bacterial Agents ; Escherichia coli/genetics ; Escherichia coli Infections/microbiology ; Humans ; Klebsiella Infections/microbiology ; Klebsiella pneumoniae/genetics ; Plasmids ; beta-Lactamases/genetics
Chemical Substances	Anti-Bacterial Agents ; beta-Lactamases (EC 3.5.2.6)
Language	English
Publishing date	2021-07-26
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	1328418-6
ISSN	1469-0691 ; 1470-9465 ; 1198-743X
ISSN (online)	1469-0691
ISSN	1470-9465 ; 1198-743X
DOI	10.1016/j.cmi.2021.07.022
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Zs.A 4541: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 284: Show issues

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Article ; Online: Household acquisition and transmission of extended-spectrum β-lactamase (ESBL) -producing Enterobacteriaceae after hospital discharge of ESBL-positive index patients.

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

2021 Volume 27, Issue 9, Page(s) 1322–1329

Abstract: Objectives: This study aimed to determine rates and risk factors of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-PE) acquisition and transmission within households after hospital discharge of an ESBL-PE-positive index patient.: ... ...

Abstract	Objectives: This study aimed to determine rates and risk factors of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-PE) acquisition and transmission within households after hospital discharge of an ESBL-PE-positive index patient. Methods: Two-year prospective cohort study in five European cities. Patients colonized with ESBL-producing Escherichia coli (ESBL-Ec) or Klebsiella pneumoniae (ESBL-Kp), and their household contacts were followed up for 4 months after hospital discharge of the index case. At each follow up, participants provided a faecal sample and personal information. ESBL-PE whole-genome sequences were compared using pairwise single nucleotide polymorphism-based analysis. Results: We enrolled 71 index patients carrying ESBL-Ec (n = 45), ESBL-Kp (n = 20) or both (n = 6), and 102 household contacts. The incidence of any ESBL-PE acquisition among household members initially free of ESBL-PE was 1.9/100 participant-weeks at risk. Nineteen clonally related household transmissions occurred (case to contact: 13; contact to case: 6), with an overall rate of 1.18 transmissions/100 participant-weeks at risk. Most of the acquisition and transmission events occurred within the first 2 months after discharge. The rate of ESBL-Kp household transmission (1.16/100 participant-weeks) was higher than of ESBL-Ec (0.93/100 participant-weeks), whereas more acquisitions were noted for ESBL-Ec (1.06/100 participant-weeks) compared with ESBL-Kp (0.65/100 participant-weeks). Providing assistance for urinary and faecal excretion to the index case by household members increased the risk of ESBL-PE transmission (adjusted prevalence ratio 4.3; 95% CI 1.3-14.1). Conclusions: ESBL-PE cases discharged from the hospital are an important source of ESBL-PE transmission within households. Most acquisition and transmission events occurred during the first 2 months after hospital discharge and were causally related to care activities at home, highlighting the importance of hygiene measures in community settings. Clinical study registration: German Clinical Trials Register, DRKS-ID: DRKS00013250.
MeSH term(s)	Enterobacteriaceae Infections/epidemiology ; Enterobacteriaceae Infections/transmission ; Escherichia coli ; Family Characteristics ; Hospitals ; Humans ; Klebsiella pneumoniae ; Patient Discharge ; Prospective Studies ; Risk Factors ; beta-Lactamases/genetics
Chemical Substances	beta-Lactamases (EC 3.5.2.6)
Language	English
Publishing date	2021-01-07
Publishing country	England
Document type	Journal Article
ZDB-ID	1328418-6
ISSN	1469-0691 ; 1470-9465 ; 1198-743X
ISSN (online)	1469-0691
ISSN	1470-9465 ; 1198-743X
DOI	10.1016/j.cmi.2020.12.024
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Article ; Online: Effect of appropriate combination therapy on mortality of patients with bloodstream infections due to carbapenemase-producing Enterobacteriaceae (INCREMENT): a retrospective cohort study.

Gutiérrez-Gutiérrez, Belén / Salamanca, Elena / de Cueto, Marina / Hsueh, Po-Ren / Viale, Pierluigi / Paño-Pardo, José Ramón / Venditti, Mario / Tumbarello, Mario / Daikos, George / Cantón, Rafael / Doi, Yohei / Tuon, Felipe Francisco / Karaiskos, Ilias / Pérez-Nadales, Elena / Schwaber, Mitchell J / Azap, Özlem Kurt / Souli, Maria / Roilides, Emmanuel / Pournaras, Spyros /

Akova, Murat / Pérez, Federico / Bermejo, Joaquín / Oliver, Antonio / Almela, Manel / Lowman, Warren / Almirante, Benito / Bonomo, Robert A / Carmeli, Yehuda / Paterson, David L / Pascual, Alvaro / Rodríguez-Baño, Jesús

The Lancet. Infectious diseases

2017 Volume 17, Issue 7, Page(s) 726–734

Abstract: Background: The best available treatment against carbapenemase-producing Enterobacteriaceae (CPE) is unknown. The objective of this study was to investigate the effect of appropriate therapy and of appropriate combination therapy on mortality of ... ...

Abstract	Background: The best available treatment against carbapenemase-producing Enterobacteriaceae (CPE) is unknown. The objective of this study was to investigate the effect of appropriate therapy and of appropriate combination therapy on mortality of patients with bloodstream infections (BSIs) due to CPE. Methods: In this retrospective cohort study, we included patients with clinically significant monomicrobial BSIs due to CPE from the INCREMENT cohort, recruited from 26 tertiary hospitals in ten countries. Exclusion criteria were missing key data, death sooner than 24 h after the index date, therapy with an active antibiotic for at least 2 days when blood cultures were taken, and subsequent episodes in the same patient. We compared 30 day all-cause mortality between patients receiving appropriate (including an active drug against the blood isolate and started in the first 5 days after infection) or inappropriate therapy, and for patients receiving appropriate therapy, between those receiving active monotherapy (only one active drug) or combination therapy (more than one). We used a propensity score for receiving combination therapy and a validated mortality score (INCREMENT-CPE mortality score) to control for confounders in Cox regression analyses. We stratified analyses of combination therapy according to INCREMENT-CPE mortality score (0-7 [low mortality score] vs 8-15 [high mortality score]). INCREMENT is registered with ClinicalTrials.gov, number NCT01764490. Findings: Between Jan 1, 2004, and Dec 31, 2013, 480 patients with BSIs due to CPE were enrolled in the INCREMENT cohort, of whom we included 437 (91%) in this study. 343 (78%) patients received appropriate therapy compared with 94 (22%) who received inappropriate therapy. The most frequent organism was Klebsiella pneumoniae (375 [86%] of 437; 291 [85%] of 343 patients receiving appropriate therapy vs 84 [89%] of 94 receiving inappropriate therapy) and the most frequent carbapenemase was K pneumoniae carbapenemase (329 [75%]; 253 [74%] vs 76 [81%]). Appropriate therapy was associated with lower mortality than was inappropriate therapy (132 [38·5%] of 343 patients died vs 57 [60·6%] of 94; absolute difference 22·1% [95% CI 11·0-33·3]; adjusted hazard ratio [HR] 0·45 [95% CI 0·33-0·62]; p<0·0001). Among those receiving appropriate therapy, 135 (39%) received combination therapy and 208 (61%) received monotherapy. Overall mortality was not different between those receiving combination therapy or monotherapy (47 [35%] of 135 vs 85 [41%] of 208; adjusted HR 1·63 [95% CI 0·67-3·91]; p=0·28). However, combination therapy was associated with lower mortality than was monotherapy in the high-mortality-score stratum (30 [48%] of 63 vs 64 [62%] of 103; adjusted HR 0·56 [0·34-0·91]; p=0·02), but not in the low-mortality-score stratum (17 [24%] of 72 vs 21 [20%] of 105; adjusted odds ratio 1·21 [0·56-2·56]; p=0·62). Interpretation: Appropriate therapy was associated with a protective effect on mortality among patients with BSIs due to CPE. Combination therapy was associated with improved survival only in patients with a high mortality score. Patients with BSIs due to CPE should receive active therapy as soon as they are diagnosed, and monotherapy should be considered for those in the low-mortality-score stratum. Funding: Spanish Network for Research in Infectious Diseases, European Development Regional Fund, Instituto de Salud Carlos III, and Innovative Medicines Initiative.
MeSH term(s)	Aged ; Anti-Bacterial Agents/therapeutic use ; Bacteremia/drug therapy ; Bacteremia/microbiology ; Bacteremia/mortality ; Bacterial Proteins ; Drug Therapy, Combination/methods ; Female ; Humans ; Klebsiella Infections/drug therapy ; Klebsiella Infections/mortality ; Klebsiella pneumoniae/drug effects ; Male ; Propensity Score ; Retrospective Studies ; Risk Factors ; beta-Lactamases
Chemical Substances	Anti-Bacterial Agents ; Bacterial Proteins ; beta-Lactamases (EC 3.5.2.6) ; carbapenemase (EC 3.5.2.6)
Language	English
Publishing date	2017-04-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(17)30228-1
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Article ; Online: A Predictive Model of Mortality in Patients With Bloodstream Infections due to Carbapenemase-Producing Enterobacteriaceae.

Gutiérrez-Gutiérrez, Belén / Salamanca, Elena / de Cueto, Marina / Hsueh, Po-Ren / Viale, Pierluigi / Paño-Pardo, José Ramón / Venditti, Mario / Tumbarello, Mario / Daikos, George / Pintado, Vicente / Doi, Yohei / Tuon, Felipe Francisco / Karaiskos, Ilias / Machuca, Isabel / Schwaber, Mitchell J / Azap, Özlem Kurt / Souli, Maria / Roilides, Emmanuel / Pournaras, Spyros /

Mayo Clinic proceedings

2016 Volume 91, Issue 10, Page(s) 1362–1371

Abstract: Objective: To develop a score to predict mortality in patients with bloodstream infections (BSIs) due to carbapenemase-producing Enterobacteriaceae (CPE).: Patients and methods: A multinational retrospective cohort study (INCREMENT project) was ... ...

Abstract	Objective: To develop a score to predict mortality in patients with bloodstream infections (BSIs) due to carbapenemase-producing Enterobacteriaceae (CPE). Patients and methods: A multinational retrospective cohort study (INCREMENT project) was performed from January 1, 2004, through December 31, 2013. Patients with clinically relevant monomicrobial BSIs due to CPE were included and randomly assigned to either a derivation cohort (DC) or a validation cohort (VC). The variables were assessed on the day the susceptibility results were available, and the predictive score was developed using hierarchical logistic regression. The main outcome variable was 14-day all-cause mortality. The predictive ability of the model and scores were measured by calculating the area under the receiver operating characteristic curve. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated for different cutoffs of the score. Results: The DC and VC included 314 and 154 patients, respectively. The final logistic regression model of the DC included the following variables: severe sepsis or shock at presentation (5 points); Pitt score of 6 or more (4 points); Charlson comorbidity index of 2 or more (3 points); source of BSI other than urinary or biliary tract (3 points); inappropriate empirical therapy and inappropriate early targeted therapy (2 points). The score exhibited an area under the receiver operating characteristic curve of 0.80 (95% CI, 0.74-0.85) in the DC and 0.80 (95% CI, 0.73-0.88) in the VC. The results for 30-day all-cause mortality were similar. Conclusion: A validated score predictive of early mortality in patients with BSIs due to CPE was developed. Trial registration: clinicaltrials.gov Identifier: NCT01 764490.
MeSH term(s)	Aged ; Anti-Bacterial Agents/therapeutic use ; Bacteremia/drug therapy ; Bacteremia/microbiology ; Bacteremia/mortality ; Bacterial Proteins/metabolism ; Comorbidity ; Decision Support Techniques ; Enterobacteriaceae/metabolism ; Enterobacteriaceae Infections/drug therapy ; Enterobacteriaceae Infections/mortality ; Female ; Humans ; Logistic Models ; Male ; Middle Aged ; Predictive Value of Tests ; Retrospective Studies ; Sensitivity and Specificity ; beta-Lactamases/metabolism
Chemical Substances	Anti-Bacterial Agents ; Bacterial Proteins ; beta-Lactamases (EC 3.5.2.6) ; carbapenemase (EC 3.5.2.6)
Language	English
Publishing date	2016-10
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Observational Study ; Validation Studies
ZDB-ID	124027-4
ISSN	1942-5546 ; 0025-6196
ISSN (online)	1942-5546
ISSN	0025-6196
DOI	10.1016/j.mayocp.2016.06.024
Database	MEDical Literature Analysis and Retrieval System OnLINE

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