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BACKGROUND: Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most important markers for the follow-up of patients infected with these viruses. Microbiology laboratories have a variety of tools to ensure the accuracy of the results obtained, including external quality control programmes such as that of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC). This article summarises the results of the 2016 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. METHODS AND RESULTS: In the HIV-1 programme, a total of 5 standards were sent. One standard consisted of seronegative human plasma, while the remaining 4 contained plasma from 3 different viremic patients, in the range of 2-5 log10 copies/mL. A significant proportion of the laboratories (40% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. The HBV and HCV programme consisted of 2 standards with different viral load contents. Most of the participants, 86.5% in the case of HCV and 85.6% in the case of HBV, obtained results that were all within the accepted range (mean ± 1.96 SD log10 UI/mL). CONCLUSIONS: Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory. Due to the marked interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow-up. Supplement information: This article is part of a supplement entitled SEIMC External Quality Control Programme. Year 2016, which is sponsored by Roche, Vircell Microbiologists, Abbott Molecular and Francisco Soria Melguizo, S.A. © 2019 Elsevier Espana, S.L.U. and Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica. All rights reserved.

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most relevant markers for the follow up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of results obtained by microbiology laboratories. This article summarized the results obtained from the 2013 SEIMC External Quality Control Programme for HIV-1, HCV, and HBV viral loads. In the HIV-1 program, a total of five standards were sent. One standard consisted in seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 2-5 log10 copies/mL; two of these standards were identical aiming to determine repeatability. A significant proportion of the laboratories (25% on average) obtained values out of the accepted range (mean ± 0.25 log10 copies/mL), depending on the standard and on the method used for quantification. Repeatability was excellent, with up to 98.9% of laboratories reporting results within the limits (D < 0.5 log10 copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 82% in the case of HCV and 78% in the HBV, obtained all the results within the accepted range (mean ± 1.96 SD log10 UI/mL). Data from this analysis reinforce the utility of proficiency programmes to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase on the overall quality. Due to the remarkable interlaboratory variability, it is advisable to use the same method and the same laboratory for patient follow up.

The spread of extended-spectrum-β-lactamase (ESBL)-producing Enterobacteriaceae (ESBL-E) is leading to increased carbapenem consumption. Alternatives to carbapenems need to be investigated. We investigated whether β-lactam/β-lactamase inhibitor (BLBLI) combinations are as effective as carbapenems in the treatment of bloodstream infections (BSI) due to ESBL-E. A multinational, retrospective cohort study was performed. Patients with monomicrobial BSI due to ESBL-E were studied; specific criteria were applied for inclusion of patients in the empirical-therapy (ET) cohort (ETC; 365 patients), targeted-therapy (TT) cohort (TTC; 601 patients), and global cohort (GC; 627 patients). The main outcome variables were cure/improvement rate at day 14 and all-cause 30-day mortality. Multivariate analysis, propensity scores (PS), and sensitivity analyses were used to control for confounding. The cure/improvement rates with BLBLIs and carbapenems were 80.0% and 78.9% in the ETC and 90.2% and 85.5% in the TTC, respectively. The 30-day mortality rates were 17.6% and 20% in the ETC and 9.8% and 13.9% in the TTC, respectively. The adjusted odds ratio (OR) (95% confidence interval [CI]) values for cure/improvement rate with ET with BLBLIs were 1.37 (0.69 to 2.76); for TT, they were 1.61 (0.58 to 4.86). Regarding 30-day mortality, the adjusted OR (95% CI) values were 0.55 (0.25 to 1.18) for ET and 0.59 (0.19 to 1.71) for TT. The results were consistent in all subgroups studied, in a stratified analysis according to quartiles of PS, in PS-matched cases, and in the GC. BLBLIs, if active in vitro, appear to be as effective as carbapenems for ET and TT of BSI due to ESLB-E regardless of the source and specific species. These data may help to avoid the overuse of carbapenems. (This study has been registered at ClinicalTrials.gov under registration no. NCT01764490.), The work was funded by the Ministerio de Economía y Competitividad, Instituto de Salud Carlos III, cofinanced by European Development Regional Fund titled A Way To Achieve Europe ERDF, the Spanish Network for Research in Infectious Diseases (REIPI RD12/0015), and FIS (PI10/02021). Participants in the study received support for research from the Innovative Medicines Initiative Joint Undertaking under the Combatting Bacterial Resistance in Europe—Molecule against Gram Negative Infections (COMBACTE-MAGNET) agreement 115737 resources, which are composed of financial contributions from the European Union's Seventh Framework Programme (FP7/2007-2013) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) companies' in kind contributions (A. Pascua and J. Rodríguez-Baño), the Cleveland Department of Veterans Affairs, the Veterans Affairs Merit Review Program, the Geriatric Research Education and Clinical Center VISN 10 (VISN 10 GRECC), and NIAID, NIH, under award numbers R01AI072219 and R01AI063517 (R. A. Bonomo).

Background. There is little information about the efficacy of active alternative drugs to carbapenems except ?-lactam/?-lactamase inhibitors for the treatment of bloodstream infections (BSIs) due to extended-spectrum ?-lactamase-producing Enterobacteriaceae (ESBL-E). The objective of this study was to assess the outcomes of patients with BSI due to ESBL-E who received empiric therapy with such drugs (other active drugs [OADs]) or carbapenems. Methods. A multinational retrospective cohort study of patients with BSI due to ESBL-E who received empiric treatment with OADs or carbapenems was performed. Cox regression including a propensity score for receiving OADs was performed to analyze 30-day all-cause mortality as main outcome. Clinical failure and length of stay were also analyzed. Results. Overall, 335 patients were included; 249 received empiric carbapenems and 86 OADs. The most frequent OADs were aminoglycosides (43 patients) and fluoroquinolones (20 patients). Empiric therapy with OADs was not associated with mortality (hazard ratio [HR], 0.75; 95% confidence interval [CI], .38-1.48) in the Cox regression analysis. Propensity score-matched pairs, subgroups, and sensitivity analyses did not show different trends; specifically, the adjusted HR for aminoglycosides was 1.05 (95% CI, .51-2.16). OADs were neither associated with 14-day clinical failure (adjusted odds ratio, 0.62; 95% CI, .29-1.36) nor length of hospital stay. Conclusions. We were unable to show that empiric treatment with OAD was associated with a worse outcome compared with carbapenems. This information allows more options to be considered for empiric therapy, at least for some patients, depending on local susceptibility patterns of ESBL-E. © The Author 2017.

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.

Objectives: Data about the efficacy of ertapenem for the treatment of bloodstream infections (BSI) due to ESBL-producing Enterobacteriaceae (ESBL-E) are limited. We compared the clinical efficacy of ertapenem and other carbapenems in monomicrobial BSI due to ESBL-E. Methods: A multinational retrospective cohort study (INCREMENT project) was performed (ClinicalTrials.gov identifier: NCT01764490). Patients given monotherapy with ertapenem or other carbapenems were compared. Empirical and targeted therapies were analysed. Propensity scores were used to control for confounding; sensitivity analyses were performed in subgroups. The outcome variables were cure/improvement rate at day 14 and all-cause 30 day mortality. Results: The empirical therapy cohort (ETC) and the targeted therapy cohort (TTC) included 195 and 509 patients, respectively. Cure/improvement rateswere 90.6% with ertapenem and 75.5% with other carbapenems (P=0.06) in the ETC and 89.8% and 82.6% (P=0.02) in the TTC, respectively; 30 day mortality rates were 3.1% and 23.3% (P=0.01) in the ETC and 9.3% and 17.1% (P=0.01) in the TTC, respectively. Adjusted ORs (95% CI) for cure/improvement with empirical and targeted ertapenem were 1.87 (0.24-20.08; P=0.58) and 1.04 (0.44- 2.50; P=0.92), respectively. For the propensity-matched cohorts it was 1.18 (0.43-3.29; P=0.74). Regarding 30 day mortality, the adjusted HR (95% CI) for targeted ertapenem was 0.93 (0.43-2.03; P=0.86) and for the propensity-matched cohorts it was 1.05 (0.46-2.44; P=0.90). Sensitivity analyses were consistent except for patients with severe sepsis/septic shock, which showed a non-significant trend favouring other carbapenems. Conclusions: Ertapenem appears as effective as other carbapenems for empirical and targeted therapy of BSI due to ESBL-E, but further studies are needed for patients with severe sepsis/septic shock. © The Author 2016.

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. © 2016 Mayo Foundation for Medical Education and Research

REIPI/ESGBIS/INCREMENT Group: J. Gálvez, M. de Cueto, E. Salamanca, M. Falcone, A. Russo, G. Daikos, I. Karaiskos, E. M. Trecarichi, A. R. Losito, D. L. Paterson, A. Hernández, J. Gómez, E. Roilides, E. Iosifidis, Y. Doi, F. F. Tuon, F. Navarro, B. Mirelis, R. San Juan, M. Fernández-Ruiz, N. Larrosa, M. Puig, J. Molina, V. González, V. Rucci, E. Ruiz de Gopegui, C. I. Marinescu, M. C. Fariñas, M. E. Cano, M. Gozalo, J. R. Paño-Pardo, C. Navarro-San Francisco, S. Gómez-Zorrilla, F. Tubau, S. Pournaras, A. Tsakris, O. Zarkotou, Ö. K. Azap, M. Souli, A. Antoniadou, G. Poulakou, D. Virmani, I. Machuca, E. Pérez-Nadales, J. Torre-Cisneros, Ö. Helvaci, A. O. Sahin, R. Cantón, P. Ruiz, M. Bartoletti, M. Giannella, F. Riemenschneider, C. Badia, M. Xercavins, D. Fontanals, E. Jové., [Objectives] Data about the efficacy of ertapenem for the treatment of bloodstream infections (BSI) due to ESBL-producing Enterobacteriaceae (ESBL-E) are limited. We compared the clinical efficacy of ertapenem and other carbapenems in monomicrobial BSI due to ESBL-E., [Methods] A multinational retrospective cohort study (INCREMENT project) was performed (ClinicalTrials.gov identifier: NCT01764490). Patients given monotherapy with ertapenem or other carbapenems were compared. Empirical and targeted therapies were analysed. Propensity scores were used to control for confounding; sensitivity analyses were performed in subgroups. The outcome variables were cure/improvement rate at day 14 and all-cause 30 day mortality., [Results] The empirical therapy cohort (ETC) and the targeted therapy cohort (TTC) included 195 and 509 patients, respectively. Cure/improvement rates were 90.6% with ertapenem and 75.5% with other carbapenems (P = 0.06) in the ETC and 89.8% and 82.6% (P = 0.02) in the TTC, respectively; 30 day mortality rates were 3.1% and 23.3% (P = 0.01) in the ETC and 9.3% and 17.1% (P = 0.01) in the TTC, respectively. Adjusted ORs (95% CI) for cure/improvement with empirical and targeted ertapenem were 1.87 (0.24–20.08; P = 0.58) and 1.04 (0.44–2.50; P = 0.92), respectively. For the propensity-matched cohorts it was 1.18 (0.43–3.29; P = 0.74). Regarding 30 day mortality, the adjusted HR (95% CI) for targeted ertapenem was 0.93 (0.43–2.03; P = 0.86) and for the propensity-matched cohorts it was 1.05 (0.46–2.44; P = 0.90). Sensitivity analyses were consistent except for patients with severe sepsis/septic shock, which showed a non-significant trend favouring other carbapenems., [Conclusions] Ertapenem appears as effective as other carbapenems for empirical and targeted therapy of BSI due to ESBL-E, but further studies are needed for patients with severe sepsis/septic shock., This study was funded by the Ministerio de Economía y Competitividad, Instituto de Salud Carlos III - co-financed by European Development Regional Fund ‘A way to achieve Europe’ ERDF, Spanish Network for the Research in Infectious Diseases (REIPI RD12/0015) and FIS (PI10/02021). The study was also supported in part by funds and/or facilities provided by the Cleveland Department of Veterans Affairs, the Veterans Affairs Merit Review Program and the Geriatric Research Education and Clinical Center VISN 10 (VISN 10 GRECC) to R. A. B. The NIAID of the NIH under Award Numbers R01AI072219 and R01AI063517 also supported R. A. B.

Objetivo: Valorar los efectos del cerclaje escleral en cirugía vitreo-retiniana, sobre la biomecánica y morfología del segmento anterior. Métodos: Estudio prospectivo: 15 ojos con desprendimiento de retina (DR), sometidos a vitrectomía pars plana (VPP) más implante de cerclaje escleral (grupo 1), y 12 ojos con hemorragia vítrea sometidos a VPP aislada (grupo 2). Se compararon pre y postoperatoriamente las propiedades biomecánicas corneales, mediante Ocular Response Analyzer (ORA): histéresis corneal (CH) y factor de resistencia corneal (CRF), además de presión intraocular Goldmann (PIOg) y presión intraocular compensada (PIOcc). Se investigó su relación con 4 parámetros morfológicos obtenidos con Orbscan IIz: potencia media de K (Mean power), desviación estándar (DE), mínimo espesor corneal (Thinnest) y profundidad de cámara anterior (ACD) Resultados: CH descendió de 10,2+/-1,7mmHg a 7,6+/-1,1 en el grupo 1 (p=0,003), pero no en el grupo 2 (9,8+/-3,2 vs 9,6+/-2,7, p=0,465). No hubo cambios en el CRF tras la cirugía. PIOg y PIOcc aumentaron significativamente en el grupo 1 (p=0,019 y p=0,010 respectivamente), pero no en el grupo 2 (p=0,715 y p=0,273). No hubo cambios significativos en los parámetros topográficos en ambos grupos (p> 0,05). Test de Wilcoxon. Conclusiones: El cerclaje escleral en la cirugía del DR no modifica significativamente la morfología del segmento anterior, luego la miopización generada se debería exclusivamente a la elongación axial del segmento posterior. La biomecánica corneal sí se altera, disminuyendo la CH. Se aporta un argumento más a favor de la VPP aislada en estas cirugías, que supondría una técnica menos agresiva quirúrgicamente. Objective: To investigate the effects of encircling scleral buckle (SB) on corneal biomechanical properties of the cornea and its morphological parameters. Methods: We prospectively examined twelve eyes diagnosed with vitreous haemorrhage undergoing pars plana vitrectomy (PPV), and fifteen eyes undergoing combined PPV and scleral buckle (PPV/SB) for repair of rhegmatogenous retinal detachment (RRD). Corneal biomechanical properties, including corneal hysteresis (CH) and corneal resistance factor (CRF), were measured with an Ocular Response Analyser (ORA) before and 1-month postoperatively. The ORA also determined the values of intraocular pressure (IOPg) and corneal compensated IOP (IOPcc). Finally, four morphological parameters of the cornea were measured with the Orbscan II topographer (Orbtek, Inc.): mean corneal power, thinnest corneal point (μm), and anterior chamber depth (ACD). Results: CH decreased significantly from 10.2+/-1.7mmHg to 7.6+/-1.1mmHg after PPV/SB (p=0.003), but not after PPV alone (9.8+/-3.2mmHg vs 11.6+/-2.7mmHg, P=.465). CRF did not change significantly after surgery in both groups. IOPg and IOPcc increased significantly in the PPV/SB group (P=.019 and P=.010, respectively) but not in PPV group (P=.715 and P=.273, respectively). Unlike the PPV group, values were significantly higher than IOPg values before (P=.001) and after surgery (P=.003) in the PPV/SB group IOPcc. Neither the PPV/SB group nor the PPV group showed any significant changes in the corneal morphological parameters after surgery (P>.05). Conclusions: SB surgery leads to a change in the corneal biomechanical properties without altering corneal morphological parameters. It may cause an underestimation error in IOP measurement. PPV may be a less invasive surgical approach for the repair of noncomplex RRD than PPV/SB.

Introducción. Las fístulas espontáneas de LCR no son una entidad frecuente y pueden ser infradiagnosticadas en el adulto. Para algunos autores, debe sospecharse esta patología en cualquier paciente mayor de 50 años con episodios de otitis serosas recurrentes y ausencia de antecedentes otológicos. La meningitis es su complicación más grave, por lo que es prioritario un diagnóstico precoz y certero. Objetivo. Presentar dos casos clínicos atendidos en nuestro servicio y revisar la literatura científica existente al respecto. Conclusión. El tratamiento de estas fístulas atraumáticas es eminentemente quirúrgico, pudiendo emplear la craneotomía de fosa media o la vía transmastoidea. En el sellado debe emplearse una técnica multicapa, combinando materiales autólogos y artificiales para conseguir mejores resultados. Introduction. Spontaneous cerebrospinal fluid otorrhea is a relatively rare entity and can be easily missed in adults. Every adult older than 50 years with a negative history of otologic disease who has recurrent serous otitis media should be evaluated for this pathology. Meningitis is the most serious complication, so there is no doubt that the condition needs immediate attention and correction. Objective. We present two patients who were diagnosed with spontaneous CSF otorrhea and make a review of what is reported about this topic. Conclusion. Surgical repair is mandatory to seal these nontraumatic CSF leaks. There are two main surgical approaches, the middle fossa craniotomy and the transmastoid approach. A multilayered closure technique in which autologous and artificial materials are combined is considered to result in the highest rate of success.

Background: The aim of the study was to determine clinical and microbiological differences between patients with methicillin-resistant Staphylococcus aureus (MRSA) catheter-related bacteraemia (CRB) undergoing or not undergoing haemodialysis, and to compare outcomes. Methods: Prospective multicentre study conducted at 21 Spanish hospitals of patients with MRSA bacteraemia diagnosed between June 2008 and December 2009. Patients with MRSA-CRB were selected. Data of patients on haemodialysis (HD-CRB) and those not on haemodialysis (non-HD-CRB) were compared. Results: Among 579 episodes of MRSA bacteraemia, 218 (37.7 %) were CRB. Thirty-four (15.6 %) were HD-CRB and 184 (84.4 %) non-HD-CRB. All HD-CRB patients acquired the infection at dialysis centres, while in 85.3 % of the non-HD-CRB group the infection was nosocomial (p < .001). There were no differences in age, gender or severity of bacteraemia (Pitt score); comorbidities (Charlson score >= 4) were higher in the HD-CRB group than in the non-HD-CRB group (73.5 % vs. 46.2 %, p = .003). Although there were no differences in VAN-MIC >= 1.5 mg/L according to microdilution, using the E-test a higher rate of VAN-MIC >= 1.5 mg/L was observed in HD-CRB than in non-HD-CRB patients (63.3 % vs. 44.1 %, p = .051). Vancomycin was more frequently administered in the HD-CRB group than in the non-HD-CRB group (82.3 % vs. 42.4 %, p =, This study was supported by Ministerio de Ciencia e Innovacion, Instituto de Salud Carlos III (FIS 08/0335) and co-financed by the European Development Regional Fund 'A way to achieve Europe' ERDF, Spanish Network for Research in Infectious Diseases (REIPI RD06/0008).; O. G. was recipient of a Rio Hortega Grant (CM08/228) from the Instituto de Salud Carlos III.