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The study of SARS-CoV-2 antibodies in the population is a crucial step towards overcoming the COVID-19 pandemic. Seroepidemiological studies allow an estimation of the number of people who have been exposed to the virus, as well as the number of people who are still susceptible to infection.In total, 13 560 people from Arganda del Rey, Madrid (Spain) were assessed between January and March 2021 for the presence of IgG antibodies, using rapid tests and histories of symptoms compatible with COVID-19.24.2% of the participants had IgG antibodies and 9% had a positive COVID-19 diagnosis. Loss of smell/taste was the most discriminating symptom of the disease. The main transmitters of infection were found to be household members. Unexpectedly, in smokers, the incidence of positive COVID-19 diagnoses was significantly lower. Additionally, it was found that there was a discrepancy between COVID-19 diagnosis and the presence of IgG antibodies.Rapid anti-IgG tests are less reliable in detecting SARS-CoV-2 infection at an individual level, but are functional in estimating SARS-CoV-2 infection rates at an epidemiological level. The loss of smell/taste is a potential indicator for establishing COVID-19 infection.

SUMMARYThe currently expanding monkeypox epidemic is caused by a subclade IIb descendant of a monkeypox virus (MPXV) lineage traced back to Nigeria in 1971. In contrast to monkeypox cases caused by clade I and subclade IIa MPXV, the prognosis of current cases is generally favorable, but person-to-person transmission is much more efficient. MPXV evolution is driven by selective pressure from hosts and loss of virus–host interacting genes. However, there is no satisfactory genetic explanation using single-nucleotide polymorphisms (SNPs) for the observed increased MPXV transmissibility. We hypothesized that key genomic changes may occur in the genome’s low-complexity regions (LCRs), which are highly challenging to sequence and have been dismissed as uninformative. Using a combination of highly sensitive techniques, we determined a first high-quality MPXV genome sequence of a representative of the current epidemic with LCRs resolved at unprecedented accuracy. This effort revealed significant variation in short-tandem repeats within LCRs. We demonstrate that LCR entropy in the MPXV genome is significantly higher than that of SNPs and that LCRs are not randomly distributed.In silicoanalyses indicate that expression, translation, stability, or function of MPXV orthologous poxvirus genes (OPGs) 153, 204, and 208 could be affected in a manner consistent with the established “genomic accordion” evolutionary strategies of orthopoxviruses. Consequently, we posit that genomic studies focusing on phenotypic MPXV clade-/subclade-/lineage-/strain differences should change their focus to the study of LCR variability instead of SNP variability.

ADVIA Centaur SARS-CoV-2 Antigen (COV2Ag) Assay (Siemens Healthineers) was evaluated for SARS-CoV-2 detection. A total of 141 nasopharyngeal samples were analyzed by this technique and results were compared with those obtained by quantitative reverse-transcription polymerase chain reaction (RT-PCR). The overall sensitivity and specificity of the test were 68.70% and 70%, respectively. Regarding cycle threshold (Ct) values, the COV2Ag test showed a sensitivity of 93.75% and 100% for nasopharyngeal samples with Ct

Monkeypox is the most prevalent Orthopoxvirus zoonosis infection since the eradication of smallpox. The current multi-country outbreak involves five WHO regions affecting mainly Europe. Accurate clinical and virological aspects of the disease outside endemic areas are needed.We performed an observational study of cases diagnosed in Madrid (Spain) (May/June 2022). Confirmation from vesicular lesions swabs, Orthopoxvirus real-time PCR, sequencing, phylogenetic analysis, and direct detection by Electron microscopy was performed. In addition, a structured epidemiological questionnaire was completed systematically to gather sociodemographic, clinical, and behavioral data from all confirmed cases.We extracted data from 48 patients, all cisgender men. The median age was 35 years (IQR 29 - 44), and 87.5% were MSM. The most prevalent symptoms were the presence of vesicular-umbilicated and pseudo-pustular skin lesions (93.8%), asthenia (66.6%), and fever (52.1%). In addition, the location of the lesions in the genital or perianal area was related to the role in sexual intercourse (p0.001). Sequencing analysis indicated the virus circulating in Spain belongs to the western African clade. Like the other European cases in the outbreak, the Spanish isolates are a direct descendant of viruses previously detected in Nigeria, the UK, Singapore, and Israel in 2017-2018.Monkeypox is an emerging infectious disease in Europe where community transmission is reported, mainly in MSM. The first symptom was skin lesions instead of classical fever and rash. The disease follows a self-limited course, and there have been no cases with a serious presentation or severe complications.

The standard RT-PCR assay for COVID-19 is laborious and time-consuming, limiting the availability of testing. Rapid antigen-detection tests are faster and less expensive; however, the reliability of these tests must be validated before they can be used widely. The objective of this study was to determine the reliability of the PanbioTM COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) for SARS-CoV-2 in nasopharyngeal swab specimens. This was a prospective multicenter study in ten Spanish university hospitals of patients from hospital units with clinical symptoms or epidemiological criteria for COVID-19. Patients whose onset of symptoms or exposure was more than 7 days earlier were excluded. Two nasopharyngeal exudate samples were taken to perform the PanbioRT and a diagnostic RT-PCR test. Among the 958 patients studied, 359 (37.5%) were positive by RT-PCR and 325 (33.9%) were also positive by the PanbioRT. Agreement was 95.7% (kappa score: 0.90). All 34 false-negative PanbioRT results were in symptomatic patients, with 23.5% of them at 6–7 days since the onset of symptoms and 58.8% presenting CT >30 values for RT-PCR, indicating a low viral load. Overall sensitivity and specificity for the PanbioRT were 90.5% and 98.8%, respectively. The PanbioRT provides good clinical performance as a point-of-care test, with even more reliable results for patients with a shorter clinical course of the disease or a higher viral load. While this study has had a direct impact on the national diagnostic strategy for COVID-19 in Spain, the results must be interpreted based on the local epidemiological context.

espanolObjetivo. Evaluar la capacidad de MALDI-TOF MS (Matrixassisted Laser Desorption-Ionization Time Of Flight) y rep-PCR para discriminar diferentes clones de Acinetobacter baumannii. Material y metodos. Se incluyeron en el estudio 21 aislados de A. baumannii con diferentes caracteristicas epidemiologicas y fenotipicas. Todas las muestras se analizaron en paralelo por MALDI-TOF MS y rep-PCR y los espectros obtenidos se compararon entre ellos y con los resultados obtenidos mediante electroforesis en campo pulsado (PFGE). Se considero que los aislados con una similitud igual o superior al 87% formaban parte del mismo grupo clonal. Resultados. El analisis de los 21 aislados incluidos en el estudio, dio lugar a 9 grupos clonales en PFGE, 3 grupos en MALDI-TOF MS y 7 grupos en el analisis mediante rep-PCR. Los aislados que formaban los diferentes grupos por las 3 tecnicas utilizadas eran totalmente diferentes, por lo que se puede concluir que no hay equivalencia entre los resultados obtenidos con los tres metodos de tipado utilizados. Conclusiones. A pesar de su simplicidad ni MALDI-TOF MS ni rep-PCR pueden sustituir en este momento al PFGE para el estudio epidemiologico de A. baumannii. EnglishObjective. To evaluate the ability of MALDI-TOF MS and rep-PCR to discriminate Acinetobacter baumannii clones. Material and methods. A total of 21 strains of A. baumannii with different epidemiological and phenotipycal characteristics were included in the study. All isolates were analyzed in parallel by MALDI-TOF MS and rep-PCR and the spectra obtained were compared with each other and with the results obtained by pulsed field gel electrophoresis (PFGE). Isolates with a similarity equal to or greater than 87% were considered to be part of the same clonal group Results. The analysis of the 21 isolates included in the study, resulted in 8 clonal groups using PFGE, 3 groups by MALDI-TOF MS and 7 groups by rep-PCR analysis. The isolates that formed the different groups by the 3 techniques used were totally different, so it can be concluded that there is no equivalence between the results obtained with the three typing methods used. Conclusions Despite its simplicity, neither MALDI-TOF MS nor rep-PCR can at this time replace PFGE for the epidemiological study of A. baumannii.

Resumen Introduccion La poblacion que se inyecta droga presenta una alta prevalencia de VHC y elevado riesgo de transmision. Es prioritario establecer un plan agil de diagnostico y tratamiento. Objetivos 1) Valorar la efectividad de un nuevo plan asistencial coordinado de derivacion desde el Centro de Atencion Integral al Drogodependiente (CAID) a atencion especializada y 2) conocer la prevalencia del VHC, caracteristicas clinicas, efectividad y seguridad del tratamiento en esta poblacion. Metodos Se analizaron retrospectivamente 1.300 serologias solicitadas por el CAID entre 1998-2018, se calculo la seroprevalencia de VHC y se valoro la eficiencia del circuito clasico de derivacion CAID-atencion especializada. Se diseno un plan asistencial coordinado entre especialistas implicados en el diagnostico y tratamiento. Desde octubre de 2018 se incluyeron 11 pacientes en el nuevo plan y se comparo el rendimiento de ambos circuitos de derivacion. Resultados Con el circuito clasico, se perdio un 48,2% (83/172) de los pacientes. Un 14,5% (172/1.300) presentaron serologia VHC positiva, en comparacion con poblacion general OR = 19; IC 95% 14,3-25. La prevalencia de infeccion activa fue del 80,3% (90/112). Con el nuevo circuito acudieron el 100% (11/11) (p = 0,0003). De los 11 pacientes derivados mediante el nuevo plan, 76,9% (8/11) tenian infeccion activa y el 100% (8/8) fueron tratados con agentes antivirales directos con exito. Conclusiones El nuevo plan asistencial coordinado CAID-atencion especializada presenta alta efectividad, en comparacion con el circuito clasico de derivacion. La seroprevalencia y prevalencia de infeccion activa en la poblacion del CAID es muy elevada. Los tratamientos con agentes antivirales directos son efectivos y seguros.

Patients with antibody deficiency disorders, such as common variable immunodeficiency (CVID), or secondary immunodeficiency (SIDs) to B-cell lymphoproliferative disorder (B-CLPD), are two vulnerable groups of developing severe or chronic form of coronavirus disease caused by SARS-CoV-2 (COVID-19). Data on adaptive immune responses against SARS-CoV-2 is well described in healthy donors, but still limited in patients with antibody deficiency of different cause. Herein, we analyzed Spike-specific IFN-γ and anti-Spike IgG antibody responses at 3 and 6 months after exposure to SARS-CoV-2 derived from vaccination and infection in two cohorts of immunodeficient patients (CVID vs. SID) compared to healthy controls (HC). Baseline cellular responses before vaccine administration were measured in 10 CVID patients. Adequate specific cellular responses was observed in 18 out of 20 (90%) CVID patients, in 14 out of 20 (70%) out of 20 SID patients and in 74 out of 81 (96%) HC. Specific IFN-γ response was significantly higher in HC respect to CVID (1,908.5 mUI/ml versus 1,694.1 mUI/ml; p = 0.005). Pre-vaccine anti-SARS-CoV-2 cellular responses were detectable in 4 out of 10 CVID patients, who had COVID-19 prior to vaccination, noticing an increase in cellular responses after vaccination (p p = 0.040), without significant differences between CVID and HC (p = 0.123) and between CVID and SID (p = 0.683). High proportions of CVID and SID patients showed adequate specific cellular responses to S1 neoantigen, with divergence between cellular and humoral immune responses in CVID and SID patients. Our data might support the relevance of these immunological studies to determine the correlate of protection to severe disease and for deciding the need of additional boosters. Follow-up studies are required to evaluate the duration and variability of the immune response to COVID-19 vaccination or infection.

The main purpose of this study is to evaluate the presence of viral RNA of severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) in conjunctival swab specimen of coronavirus disease 2019 (COVID‐19) patients with and without conjunctivitis to establish the diagnostic value of reverse transcription‐polymerase chain reaction (RT‐PCR) in each case and to describe its clinical characteristics. A cross‐sectional study was conducted at the Hospital Clinico San Carlos of Madrid, Spain. Thirty‐six subjects from the COVID admission unit with laboratory‐confirmed SARS‐CoV‐2 infection were included. Conjunctival swabs were collected from 18 patients with conjunctivitis and 18 patients without conjunctivitis and RT‐PCR was performed. Conjunctival swab was collected from both eyes of 36 patients (72 eyes), detecting SARS‐CoV‐2 RNA in conjunctival swab of two patients (5.5%). Among the 18 patients with conjunctivitis, only one of them (5.5%) showed positive results. Likewise, SARS‐CoV‐2 RNA was detected in one patient without conjunctivitis (5.5%). The mean age of the 36 patients was 67.9 years (range, 28‐92 years) and the male‐to‐female ratio was 0.44 (16:20). The mean days since the onset of COVID‐19 symptoms until conjunctivitis manifestation was 8 (range, 1‐24 days). The mean duration of the conjunctivitis was 3 days (range, 1‐7 days). SARS‐CoV‐2 RNA may be detected in conjunctival swabs of both patients with and without conjunctivitis. This study revealed the same rate of positive results amongst the group with and without conjunctivitis, suggesting that detecting SARS‐CoV‐2 in ocular fluids is not conditioned on the presence of conjunctivitis. The presence of SARS‐CoV‐2 RNA in ocular samples highlights the role of the eye as a possible route of transmission of the disease., Highlights SARS‐CoV‐2 RNA can be detected in conjunctival secretions of both patients with and without conjunctivitis. However, PCR essay of tears and conjunctival secretions appear to have a fairly low potential of detecting the virus.

espanolObjetivo. Las infecciones relacionadas con la asistencia sanitaria (IRAS) son un problema de salud publica, siendo las infecciones de localizacion quirurgica (ILQ) las mas frecuentes a nivel hospitalario. El objetivo de este estudio fue evaluar el efecto de la adecuacion de la profilaxis antibiotica en la incidencia de infeccion quirurgica en pacientes histerectomizadas. Material y metodos. Se realizo un estudio de cohortes prospectivo entre octubre de 2009 y diciembre de 2018. Se estudio la incidencia de ILQ durante los primeros 30 dias tras la cirugia. Se evaluo el grado de adecuacion de la profilaxis antibiotica en histerectomia y el efecto de su inadecuacion en la incidencia de infeccion con el riesgo relativo (RR) ajustado mediante un modelo de regresion logistica. Resultados. Se estudiaron 1.025 intervenciones en 1.022 mujeres. La incidencia acumulada de ILQ fue del 2,1% (n=22) y la etiologia mas frecuente Escherichia coli (23,1%) y Proteus mirabilis (23,1%). La profilaxis antibiotica estaba indicada en 1.014 intervenciones (98,9%) administrandose en 1.009 de ellas (99,5%), con una adecuacion general al protocolo del 92,5%. La causa principal de no cumplimiento fue el tiempo de inicio (40,9%), seguida por la eleccion del antibiotico (35,2%). El efecto de la inadecuacion de la profilaxis sobre la incidencia de infeccion fue de RR=0,9; IC95% 0,2-3,9; p>0,05. Conclusiones. La adecuacion de la profilaxis antibiotica fue muy alta, con una baja incidencia de infeccion quirurgica. No se encontro asociacion entre adecuacion de la profilaxis e incidencia de infeccion en histerectomia. Se debe insistir en la mejora continua de la vigilancia epidemiologica en ginecologia. EnglishObjectives. Health care-related infections are a public health problem, among them surgical site infection (SSI) are the most frequent in hospitals. The objetive of this study was to assess the effect of the compliance to antibiotic prophylaxis protocol on the incidence of surgical site infection in hysterectomized patients. Material and methods. A prospective cohort study was carried out between October 2009 and December 2018. The incidence of SSI was studied after a maximum period of 30 days from the moment of surgery. The degree of adequacy of antibiotic prophylaxis in hysterectomy and the effect of its inadequacy on the incidence of infection was evaluated using relative risk (RR) adjusted with a logistic regression model. Results. A total of 1,025 interventions were studied in 1,022 women. The cumulative incidence of SSI was 2,1% (n = 22). The most frequent etiology of infection was Escherichia coli (23.1%) and Proteus mirabilis (23.1%). Antibiotic prophylaxis was indicated in 1,014 interventions (98.9%) being administered in 1,009 of them (99.5%). The adherence to the protocol was 92,5%. The main cause of non-compliance was the time of onset (40.9%), followed by the choice of the antibiotic (35.2%). The effect of inadequate prophylaxis on the incidence of infection was RR = 0.9; 95% CI 0.2-3.9; p> 0.05. Conclusions. The adequacy of antibiotic prophylaxis was very high, with a low incidence of surgical site infection. No association was found between adequacy of prophylaxis and incidence of infection in hysterectomy. The continuous improvement of epidemiological surveillance in gynecology should be emphasized.

Background:Although most cases of SARS-CoV-2 infection in pediatric population are asymptomatic or mild, severe cases may occur in a small percentage. Unlike other respiratory infections, children usually develop it from infected adults. Percentage of seroconversión and outcome of antibodies after infection anti-SAR-CoV-2 in children are still poorly understood and may be different from adults. The first aim was to describe clinical and epidemiological characteristics of pediatric patients diagnosed of SARS-CoV-2 infection in the second epidemic wave in two tertiary hospitals in Madrid, Spain and to determine the proportion of seronegative by comparing 3 serological techniques. As secondary aim it was proposed to determine the proportion of seronegative by comparing 3 serological techniques, seroconversion associated variables and the way of infection among the family members. Methods:Multicenter prospective observational study in two university hospitals of the Community of Madrid, between September and November 2020, of COVID-19 infection confirmed by PCR in the Emergency Department. A retrospective data collection was performed at 4-8 weeks after diagnosis on an outpatient basis, using a clinical-epidemiological questionnaire. At this time blood samples were collected to analyse the humoral response by 3 different serological assays.The quantitative variables are expressed as medians (interquartile range (IQR) 25-75).Univariate analysis of possible factors associated with seropositivity absence was performed.Results: One hundred and eleven patients (58 girls) were included with a median days of 37 (IQR: 34-44) between diagnosis and serologic test performed.Median age was 88 (IQR: 24-149) months. Parents were from abroad in 62 cases (50% from South and Central America).Ninety eight children were symptomatic, 17 children were diagnosed by epidemiological screening, 4 of whom subsequently developed symptoms.Eight of them needing admission with a median length of stay 2 days (IQR: 2-4), none of them in PICU.Underlying conditions were found in 33 patients, mainly recurrent bronchitis.Most frequent symptoms (70%) were low-grade fever (37-38ºC) or fever (≥ 38ºC), rhinorrhea 44%, cough 31.5%, headache 29.7%, weakness 27%, diarrhea 19.8%, abdominal pain and vomiting 26%, anosmia 16.2% (median 10 days; IQR: 6-30). Infection was interpreted as a secondary case in 56 patients, being a relative the index case in 96.4%. Seronegativity was observed in 19 patients in any of the 3 serological techniques (17.1%; 95% CI: 10.6-25.4), this proportion was higher among children aged 2-to 10-year-old age (16 of 45; 35%, p Conclusions: Our results confirm the mild clinical picture in children during the second epidemic wave, and that in most cases, children are not the index case in the family. Likewise, in children the proportion in whom seroconversion is not detected is high, and seems higher than that reported in adults. In our series, an association of seronegativity was seen in the 2 to 10 year-old age group and when there was no documentation of COVID-19 in any household contact.

SARS‐CoV‐2 rapid detection is of great interest to prevent viral dissemination. In that sense, antigen tests appeared as a very valuable tool to reach this goal. However, it is possible to obtain a negative result in those patients with low viral loads, and consequently, reverse transcription‐polymerase chain reaction (RT‐PCR) should be performed on samples from patients with a negative antigen test in which there is a strong suspicion of COVID infection. The common diagnostic algorithm involves taking a second sample for RT‐PCR testing. This study evaluates the usefulness of the antigen test sample for carrying out RT‐PCR analysis when necessary. Results obtained indicate that can be used a unique sample for both antigen test and RT‐PCR. This data showed that it is possible to reduce excessive suspected individuals managing and so on increase staff security and patient comfort.

BACKGROUND: The importance of submicroscopic malaria infections in high-transmission areas could contribute to maintain the parasite cycle. Regarding non-endemic areas, its importance remains barely understood because parasitaemia in these afebrile patients is usually below the detection limits for microscopy, hence molecular techniques are often needed for its diagnosis. In addition to this, the lack of standardized protocols for the screening of submicroscopic malaria in immigrants from endemic areas may underestimate the infection with Plasmodium spp. The aim of this study was to assess the prevalence of submicroscopic malaria in afebrile immigrants living in a non-endemic area. METHODS: A prospective, observational, multicentre study was conducted. Afebrile immigrants were included, microscopic observation of Giemsa-stained thin and thick blood smears, and two different molecular techniques detecting Plasmodium spp. were performed. Patients with submicroscopic malaria were defined as patients with negative blood smears and detection of DNA of Plasmodium spp. with one or both molecular techniques. Demographic, clinical, analytical and microbiological features were recorded and univariate analysis by subgroups was carried out with STATA v15. RESULTS: A total of 244 afebrile immigrants were included in the study. Of them, 14 had a submicroscopic malaria infection, yielding a prevalence of 5.7% (95% confidence interval 3.45-9.40). In 71.4% of the positive PCR/negative microscopy cases, Plasmodium falciparum alone was the main detected species (10 out of the 14 patients) and in 4 cases (28.6%) Plasmodium vivax or Plasmodium ovale were detected. One patient had a mixed infection including three different species. CONCLUSIONS: The prevalence of submicroscopic malaria in afebrile immigrants was similar to that previously described in Spain. Plasmodium vivax and P. ovale were detected in almost a third of the submicroscopic infections. Screening protocols for afebrile immigrants with molecular techniques could be useful for a proper management of these patients. This work was funded by projects PI14/01671, PI17/01791 and PI14CIII/00014, from the Instituto de Salud Carlos III (Ministry of Economy, Industry and Competitiveness) and cofounded by the European Regional Development Fund, and approved by the Ethics Committee of our Institution. There was no funding from the PCR manufacturers; they did not play any role in data analysis or in the reporting of the results. Sí

Early detection of SARS-CoV-2 is essential for a timely update of health policies and allocation of resources. Particularly, serological testing may allow individuals with low-risk of being contagious of SARS-CoV-2 to return to daily activities. Both private and academic initiatives have sought to develop serological assays to detect anti-SARS-CoV-2 antibodies. Herein, we compared five different assays in active healthcare personnel exposed to SARS-CoV-2 in a large center in Madrid, Spain, in a retrospective study. Median time lapse between polymerase chain-reaction (PCR) and serological testing was 11 days (7–21). All tests assessed IgM/IgG titers except for Euroimmun (IgA/IgG) and The Binding-Site (IgA/IgM/IgG). The highest concordance rate was observed between Dia.Pro and Euroimmun (75.76%), while it was lowest between The Binding-Site and Euroimmun (44.55%). The Binding-Site assay showed the highest concordance (85.52%) with PCR results. Considering PCR results as reference, Dia.Pro was the most sensitive test, although The Binding-Site assay exhibited the highest area under the curve (AUC, 0.85). OrientGene and MAGLUMI tests were performed in a smaller cohort with confirmed infection and thus were not adequate to estimate sensitivity and specificity. The Binding-Site assay presented the best joint sensitivity and specificity among all the tests analyzed in our cohort. Likewise, this serological assay presents a greater repertoire of antibodies and antigen-regions tested, which is why each individual’s humoral immunity is more accurately reflected. The better the immunity test, the most adequate the health strategy to take in terms of organization of consultations, surgery, and treatments in vulnerable patients. The three antibody classes (IgG/IgM/IgA) were determined jointly, which translates to an economic impact on healthcare. While their role in the protection status remains elusive, serological tests add a valuable tool in the early management of SARS-CoV-2 after known exposition.

REIPI-SEIMC COVID-19 group and COVID@HULP group., [Background] The clinical presentation of COVID-19 in patients admitted to hospital is heterogeneous. We aimed to determine whether clinical phenotypes of patients with COVID-19 can be derived from clinical data, to assess the reproducibility of these phenotypes and correlation with prognosis, and to derive and validate a simplified probabilistic model for phenotype assignment. Phenotype identification was not primarily intended as a predictive tool for mortality., [Methods] In this study, we used data from two cohorts: the COVID-19@Spain cohort, a retrospective cohort including 4035 consecutive adult patients admitted to 127 hospitals in Spain with COVID-19 between Feb 2 and March 17, 2020, and the COVID-19@HULP cohort, including 2226 consecutive adult patients admitted to a teaching hospital in Madrid between Feb 25 and April 19, 2020. The COVID-19@Spain cohort was divided into a derivation cohort, comprising 2667 randomly selected patients, and an internal validation cohort, comprising the remaining 1368 patients. The COVID-19@HULP cohort was used as an external validation cohort. A probabilistic model for phenotype assignment was derived in the derivation cohort using multinomial logistic regression and validated in the internal validation cohort. The model was also applied to the external validation cohort. 30-day mortality and other prognostic variables were assessed in the derived phenotypes and in the phenotypes assigned by the probabilistic model., [Findings] Three distinct phenotypes were derived in the derivation cohort (n=2667)—phenotype A (516 [19%] patients), phenotype B (1955 [73%]) and phenotype C (196 [7%])—and reproduced in the internal validation cohort (n=1368)—phenotype A (233 [17%] patients), phenotype B (1019 [74%]), and phenotype C (116 [8%]). Patients with phenotype A were younger, were less frequently male, had mild viral symptoms, and had normal inflammatory parameters. Patients with phenotype B included more patients with obesity, lymphocytopenia, and moderately elevated inflammatory parameters. Patients with phenotype C included older patients with more comorbidities and even higher inflammatory parameters than phenotype B. We developed a simplified probabilistic model (validated in the internal validation cohort) for phenotype assignment, including 16 variables. In the derivation cohort, 30-day mortality rates were 2·5% (95% CI 1·4–4·3) for patients with phenotype A, 30·5% (28·5–32·6) for patients with phenotype B, and 60·7% (53·7–67·2) for patients with phenotype C (log-rank test p, [Interpretation] Patients admitted to hospital with COVID-19 can be classified into three phenotypes that correlate with mortality. We developed and validated a simplified tool for the probabilistic assignment of patients into phenotypes. These results might help to better classify patients for clinical management, but the pathophysiological mechanisms of the phenotypes must be investigated., [Funding] Instituto de Salud Carlos III, Spanish Ministry of Science and Innovation, and Fundación SEIMC/GeSIDA., Funding: Instituto de Salud Carlos III, Spanish Ministry of Science and Innovation, and Fundación SEIMC/GeSIDA.

e24072 Background: SARS-CoV-2 vaccines efficacy and safety have been tested in phase 3 studies which did not include cancer patients. Information is scarce regarding COVID-19 vaccines safety in this population. Methods: The objective of this study is to evaluate the safety profile of the mRNA-1273 vaccine across cancer patients and its relationship to patients’ demographics. This cross sectional study included patients 18-years or older with solid malignancies receiving active treatment in Hospital Clínico San Carlos (Madrid, Spain) who had received the three dose schedule of the mRNA9 1273 vaccine. Patient electronic medical records were reviewed retrospectively to collect data between April 19, 2021 and December 31, 2021. Patients with documented previous infection by SARS-Cov-2 were excluded. Results: 93 patients met inclusion criteria. 31 patients (33%) were male and 62 patients (66%) were female. Mean age was 61 [SD 8]. 33% of the study population had metastatic disease. The majority of patients (60%) had ECOG 0 whereas 32% and 8% of the population had ECOG 1 and 2 respectively. Most common tumors were breast (33%) and gastrointestinal (17%). Treatment modalities included chemotherapy (37%), targeted therapy (23%), immunotherapy (12%) and combined therapy (28%). Local adverse effects at the site of injection and systemic adverse reactions had different trends, local adverse reactions were reported more frequently after the first and second dose than after the third (42%, 50% and 36% respectively), while systemic adverse reactions were reported less frequently after the first and second dose than after the third (16%, 35% and 53% respectively). Most common systemic adverse effect was fever followed by malaise and myalgia. No grade 4 or 5 adverse events were reported. We found a statistically significant association between sex and systemic adverse reactions after the third dose with a moderate correlation assessed by Cramer’s V. Cochran-Armitage test showed a statistically significant linear trend, p = 0.012, with higher ECOG score associated with a lower proportion of patients suffering from systemic side effects. A logistic regression showed that females had 5.79 times higher odds to exhibit systemic adverse events after the third dose (p = 0.01) compared to males. Increasing age was associated with a decreased likelihood of exhibiting adverse events (p = 0.016). ECOG scores didn’t show a statistically significant association. Conclusions: mRNA-1273 vaccine shows a tolerable safety profile, which is similar to the non-oncologic population. The likelihood of adverse reactions appears to be associated with gender and age. Its association with ECOG scores is less evident. Further studies are needed to elucidate the safety profile of COVID-19 vaccines in cancer patients.

Introduction The drug-injecting population has a high prevalence of hepatitis C virus (HCV) and high risk of transmission. It is a priority to establish an agile diagnostic and treatment plan. Objectives 1) Assess the effectiveness of a new coordinated care plan of referral from the Comprehensive Care Centre for Drug Addicts (CAID) to specialised care and 2) Determine the prevalence of HCV, clinical characteristics, effectiveness and safety of treatment in this population. Methods 1300 serologies requested by the CAID between 1998 and 2018 were retrospectively analysed, the seroprevalence of HCV was calculated and the efficiency of the traditional CAID-specialised care referral system was evaluated. A care plan was designed and coordinated among specialists involved in diagnosis and treatment. Since October 2018, 11 patients have been included in the new plan and the performance of both referral systems was compared. Results With the traditional system, 48.2% (83/172) of the patients were lost. 14.5% (172/1300) presented positive HCV serology, compared to the general population OR = 19; 95% CI 14.3−25. The prevalence of active infection was 80.3% (90/112). The prevalence of active infection was 80.3% (90/112). Of the 11 patients referred by the new plan, 76.9% (8/11) had active infection and 100% (8/8) were treated with Direct Antiviral Agents successfully. Conclusions The new coordinated CAID-specialised care plan presents high effectiveness in comparison with the traditional referral system. The seroprevalence and prevalence of active infection in the CAID population is very high. Treatments with Direct Antiviral Agents are effective and safe.

Recurrence of Clostridium difficile infection (CDI) has major consequences for both patients and the health system. The ability to predict which patients are at increased risk of recurrent CDI makes it possible to select candidates for treatment with new drugs and therapies (including fecal microbiota transplantation) that have proven to reduce the incidence of recurrence of CDI. Our objective was to develop a clinical prediction tool, the GEIH-CDI score, to determine the risk of recurrence of CDI. Predictors of recurrence of CDI were investigated using logistic regression in a prospective cohort of 274 patients diagnosed with CDI. The model was calibrated using the Hosmer-Lemeshow test. The tool comprises four factors: age (70-79 years and >= 80 years), history of CDI during the previous year, direct detection of toxin in stool, and persistence of diarrhea on the fifth day of treatment. The functioning of the GEIH-CDI score was validated in a prospective cohort of 183 patients. The area under the ROC curve was 0.72 (0.65-0.79). Application of the tool makes it possible to select patients at high risk (> 50%) of recurrence and patients at low risk (< 10%) of recurrence. GEIH-CDI score may be useful for clinicians treating patients with CDI. (C) 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

Objectives RT-PCR assay is the reference method for diagnosis of COVID-19, but it is also a laborious and time-consuming technic, limiting the availability of testing. Rapid antigen-detection tests are faster and less expensive; however, the reliability of these tests must be validated before they can be used widely. The objective of this study was to determine the performance of the Clinitest Rapid COVID-19 Antigen Test (ClinitestRT) (SIEMENS) for SARS-CoV-2 in nasopharyngeal swab specimens. Methods This prospective multicenter study was carried out in three Spanish university hospitals including individuals with clinical symptoms or epidemiological criteria for COVID-19. Only individuals with ≤7 days from the onset of symptoms or from exposure to a confirmed case of COVID-19 were included. Two nasopharyngeal samples were taken to perform the ClinitestRT, as a point-of-care test, and a diagnostic RT-PCR test. Results Overall sensitivity and specificity for the ClinitestRT among the 450 patients studied were 93.3% (CI 95%: 89.7–96.8) and 99.2% (CI 95%: 97.2–99.8), respectively. Sensitivity in participants with ≤5 days of the clinical course was 93.6% (CI 95%: 89.2–96.3), and in participants who had a CT

Background: micro-elimination has been recently proposed as an efficient strategy to achieve global hepatitis C virus (HCV) elimination. The Spanish Health Ministry Strategic Plan for hepatitis C infection highlighted intervention in prisons as a priority action. However, there are important barriers associated with the specialized care provision to the penitentiary population. Aims: to assess the contribution of telemedicine for HCV elimination in a correctional facility in Spain. Methods: an open label program of HCV elimination via telemedicine was started on February 3rd, 2015 in a large penitentiary of 1,200 inmates, as an alternative to referring patients to specialists. An anonymous satisfaction survey was performed among a random sample of inmates and all participating doctors. Results: the prevalence of HCV viremia prior to program initiation was 12.4%. One hundred and thirty-one patients received DAA HCV treatment during the period 2015-2018; 42.74% had a HCV-HIV co-infection. Overall, 97% achieved a sustained virological response (SVR). A second regime of DAA successfully rescued non-responder patients and the HCV prevalence was zero at the end of the program. Satisfaction was high or very high according to 67% of inmates and all participating doctors. Conclusion: telemedicine is an effective tool for HCV elimination in penitentiary correctional facilities where referral to specialists is difficult. The extensive use of this technology should be recommended in this setting in order to facilitate equitable access to specialized care.

Study group: José Romero; Alfonso Muriel; Livia Giner; Federico Ferrere; Rocío Martínez-Ruiz; Purificación Martos; Cristina Sardiña; Elena Aguirre; Cristina Badía; Alfonso Perales; Pedro A. De Santos-Castro; Angel Bratos-Pérez Miguel; Sandra Cuellar; Eva González; Pedro llinares; Laura Castelo; Isabel Morales; Alberto Delgado-Iribarren; Pilar Mairal, Clostridium difficile infection (CDI) is characterized by a high delayed and unrelated mortality. Predicting delayed mortality in CDI patients could allow the implementation of interventions that could reduce these events. A prospective multicentric study was carried out to investigate prognostic factors associated with mortality. It was based on a cohort (July 2015 to February 2016) of 295 patients presenting with CDI. Logistic regression was used and the model was calibrated using the Hosmer-Lemeshow test. The mortality rate at 75 days in our series was 18%. Age (>65 years), comorbidity (defined by heart failure, diabetes mellitus with any organ lesion, renal failure, active neoplasia or immunosuppression) and fecal incontinence at clinical presentation were associated with delayed (75-day) mortality. When present, each of the aforementioned variables added one point to the score. Mortalities with 0, 1, 2 and 3 points were 0%, 9.4%, 18.5% and 38.2%, respectively. The area under the ROC curve was 0.743, and the Hosmer-Lemeshow goodness-of-fit test p value was 0.875. Therefore, the prediction of high delayed mortality in CDI patients by our scoring system could promote measures for increasing survival in suitable cases.

[Goal]: To evaluate the effect of yogurt supplemented with probiotic bacteria on the prevention of antibiotic-associated diarrhea (AAD) in hospitalized patients., [Background]: Diarrhea following antibiotic administration is a frequent clinical problem. The usefulness of probiotics for the prevention of AAD in the hospitalized adult population remains unclear., [Study]: A randomized, double-blind, placebo-controlled clinical trial was conducted in hospitalized patients who started antibiotic treatment. Patients were randomized (2:2:1) to receive a daily amount of 200 mL of placebo-yogurt (Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus), 200 mL of probiotic yogurt (previous plus Lactobacillus acidophilus La-5, Bifidobacterium animalis subsp. lactis Bb-12 and Lactobacillus casei subsp. casei Lc-01 or no yogurt (unblinded control) within 48 hours of beginning the antibiotic therapy and up to 5 days after stopping the antibiotic. Patients were followed up with for 1 month to determine occurrence of diarrhea., [Results]: We included 314 patients, mean age 76 years. The rate of diarrhea was 23.0% in the probiotic group versus 17.6% in the placebo group, absolute risk reduction −5.35% (95% confidence interval, −15.4% to 4.7%; P=0.30). Rate of diarrhea was similar in the unblinded external control and in the blinded study groups combined (20.9% vs. 20.2% respectively; P=0.91). There was no difference in the duration of diarrhea, maximum number of bowel movements or prolonged admission because of diarrhea among the groups. All-cause mortality did not differ between groups., [Conclusions]: The combined probiotic strains LA-5, BB-12, and LC-01 do not have an effect in the prevention of AAD in hospitalized patients., This work was funded by grant AGL2004-07285-C02 of Spanish Ministry of Science.

Ceftolozane/tazobactam is a novel antibiotic approved for the treatment of complicated intra-abdominal and complicated urinary tract infections. We describe the use of off-label ceftolozane/tazobactam in the management of a multidrug-resistant Pseudomonas aeruginosa bacteremia that was already being treated with colistin and amikacin, the only active antibiotics according to the antibiogram.

The aim of this study is to report the epidemiological characteristics of a food poisoning outbreak due to scombroid fish in a hospital. A case-control study (1:4) was conducted. Patients either symptomatic of food poisoning (cases) or asymptomatic (controls) eating at the hospital cafeteria were included. To identify the source of the outbreak, sanitary control factors were assessed. Microbiological studies and the mast cell tryptase test were performed. All cases and controls received a questionnaire enquiring about symptoms and foods consumed. The odds ratios (OR) for all risk factors and their 95% confidence intervals (CI) were assessed. In total, 20 individuals (90% female) were included in the study: four cases and 16 controls. The overall mean age was 43 years (SD: 10.2). The most frequent symptom observed was facial and neck erythaema (100%). Microbiological cultures were negative, the mast cell tryptase test was normal and breakdown of the cold chain did not occur. The most likely source of the outbreak was fried anchovies (OR: 34.7; 95% CI: 1.50–809.6; p = 0.02). Methods suitable to the rapid assessment of the outbreak allowed us to establish prompt preventive measures and identify the likely aetiology. Keywords: Food poisoning, Scombroid toxin, Outbreaks, Case control studies, Public health

Background Concerns have arisen regarding the optimal antifungal regimen for Candida parapsilosis bloodstream infection (BSI) in view of its reduced susceptibility to echinocandins. Methods The Prospective Population Study on Candidemia in Spain (CANDIPOP) is a prospective multicenter, population-based surveillance program on Candida BSI conducted through a 12-month period in 29 Spanish hospitals. Clinical isolates were identified by DNA sequencing, and antifungal susceptibility testing was performed by the European Committee on Antimicrobial Susceptibility Testing methodology. Predictors for clinical failure (all-cause mortality between days 3 to 30, or persistent candidemia for ≥72 hours after initiation of therapy) in episodes of C. parapsilosis species complex BSI were assessed by logistic regression analysis. We further analyzed the impact of echinocandin-based regimen as the initial antifungal therapy (within the first 72 hours) by using a propensity score approach. Results Among 752 episodes of Candida BSI identified, 200 (26.6%) were due to C. parapsilosis species complex. We finally analyzed 194 episodes occurring in 190 patients. Clinical failure occurred in 58 of 177 (32.8%) of evaluable episodes. Orotracheal intubation (adjusted odds ratio [AOR], 2.81; P = .018) and septic shock (AOR, 2.91; P = .081) emerged as risk factors for clinical failure, whereas early central venous catheter removal was protective (AOR, 0.43; P = .040). Neither univariate nor multivariate analysis revealed that the initial use of an echinocandin-based regimen had any impact on the risk of clinical failure. Incorporation of the propensity score into the model did not change this finding. Conclusions The initial use of an echinocandin-based regimen does not seem to negatively influence outcome in C. parapsilosis BSI.