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  1. Article ; Online: Use of Monoclonal Antibodies in Immunocompromised Patients Hospitalized with Severe COVID-19

    Jorge Calderón-Parra / Pablo Guisado-Vasco / Rocío Montejano-Sánchez / Vicente Estrada / Guillermo Cuevas-Tascón / José Aguareles / José Arribas / Marta Erro-Iribarren / Marina Calvo-Salvador / Ana Fernández-Cruz / Antonio Ramos-Martínez / Elena Muñez-Rubio

    Journal of Clinical Medicine, Vol 12, Iss 864, p

    A Retrospective Multicenter Cohort

    2023  Volume 864

    Abstract: Objective: We aim to describe the safety and efficacy of sotrovimab in severe cases of COVID-19 in immunocompromised hosts. Methods: We used a retrospective multicenter cohort including immunocompromised hospitalized patients with severe COVID-19 treated ...

    Abstract Objective: We aim to describe the safety and efficacy of sotrovimab in severe cases of COVID-19 in immunocompromised hosts. Methods: We used a retrospective multicenter cohort including immunocompromised hospitalized patients with severe COVID-19 treated with sotrovimab between October 2021 and December 2021. Results: We included 32 patients. The main immunocompromising conditions were solid organ transplantation (46.9%) and hematological malignancy (37.5%). Seven patients (21.9%) had respiratory progression: 12.5% died and 9.4% required mechanical ventilation. Patients treated within the first 14 days of their symptoms had a lower progression rate: 12.0% vs. 57.1%, p = 0.029. No adverse event was attributed to sotrovimab. Conclusions: Sotrovimab was safe and may be effective in its use for immunocompromised patients with severe COVID-19. More studies are needed to confirm these preliminary data.
    Keywords COVID-19 ; monoclonal antibodies ; sotrovimab ; severe COVID-19 ; immunocompromised hosts ; Medicine ; R
    Subject code 616
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Association of COVID-19-Associated Pulmonary Aspergillosis with Cytomegalovirus Replication

    Jorge Calderón-Parra / Victor Moreno-Torres / Patricia Mills-Sanchez / Sandra Tejado-Bravo / Isabel Romero-Sánchez / Bárbara Balandin-Moreno / Marina Calvo-Salvador / Francisca Portero-Azorín / Sarela García-Masedo / Elena Muñez-Rubio / Antonio Ramos-Martinez / Ana Fernández-Cruz

    Journal of Fungi, Vol 8, Iss 161, p

    A Case–Control Study

    2022  Volume 161

    Abstract: Introduction: Cytomegalovirus (CMV) infection is a well-known factor associated with invasive aspergillosis in immunocompromised hosts. However, its association with COVID-19-associated pulmonary aspergillosis (CAPA) has not been described. We aimed to ... ...

    Abstract Introduction: Cytomegalovirus (CMV) infection is a well-known factor associated with invasive aspergillosis in immunocompromised hosts. However, its association with COVID-19-associated pulmonary aspergillosis (CAPA) has not been described. We aimed to examine the possible link between CMV replication and CAPA occurrence. Methods: A single-center, retrospective case–control study was conducted. A case was defined as a patient diagnosed with CAPA according to 2020 ECMM/ISHAM consensus criteria. Two controls were selected for each case among critically ill COVID-19 patients. Results: In total, 24 CAPA cases were included, comprising 14 possible CAPA and 10 probable CAPA. Additionally, 48 matched controls were selected. CMV replication was detected more frequently in CAPA than in controls (75.0% vs. 35.4%, p = 0.002). Probable CMV end-organ disease was more prevalent in CAPA (20.8% vs. 4.2%, p = 0.037). After adjusting for possible confounding factors, CMV replication persisted strongly associated with CAPA (OR 8.28 95% CI 1.90–36.13, p = 0.005). Among 11 CAPA cases with CMV PCR available prior to CAPA, in 9 (81.8%) cases, CMV replication was observed prior to CAPA diagnosis. Conclusions: Among critically ill COVID-19 patients, CMV replication was associated with CAPA and could potentially be considered a harbinger of CAPA. Further studies are needed to confirm this association.
    Keywords COVID-associated pulmonary aspergillosis ; CAPA ; prevalence ; risk factors ; cytomegalovirus infection ; Biology (General) ; QH301-705.5
    Subject code 610
    Language English
    Publishing date 2022-02-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Unreliability of Clinical Prediction Rules to Exclude without Echocardiography Infective Endocarditis in Staphylococcus aureus Bacteremia

    Jorge Calderón-Parra / Itziar Diego-Yagüe / Beatriz Santamarina-Alcantud / Susana Mingo-Santos / Alberto Mora-Vargas / José Manuel Vázquez-Comendador / Ana Fernández-Cruz / Elena Muñez-Rubio / Andrea Gutiérrez-Villanueva / Isabel Sánchez-Romero / Antonio Ramos-Martínez

    Journal of Clinical Medicine, Vol 11, Iss 1502, p

    2022  Volume 1502

    Abstract: Background: It is unclear whether the use of clinical prediction rules is sufficient to rule out infective endocarditis (IE) in patients with Staphylococcus aureus bacteremia (SAB) without an echocardiogram evaluation, either transthoracic (TTE) and/or ... ...

    Abstract Background: It is unclear whether the use of clinical prediction rules is sufficient to rule out infective endocarditis (IE) in patients with Staphylococcus aureus bacteremia (SAB) without an echocardiogram evaluation, either transthoracic (TTE) and/or transesophageal (TEE). Our primary purpose was to test the usefulness of PREDICT, POSITIVE, and VIRSTA scores to rule out IE without echocardiography. Our secondary purpose was to evaluate whether not performing an echocardiogram evaluation is associated with higher mortality. Methods: We conducted a unicentric retrospective cohort including all patients with a first SAB episode from January 2015 to December 2020. IE was defined according to modified Duke criteria. We predefined threshold cutoff points to consider that IE was ruled out by means of the mentioned scores. To assess 30-day mortality, we used a multivariable regression model considering performing an echocardiogram as covariate. Results: Out of 404 patients, IE was diagnosed in 50 (12.4%). Prevalence of IE within patients with negative PREDICT, POSITIVE, and VIRSTA scores was: 3.6% (95% CI 0.1–6.9%), 4.9% (95% CI 2.2–7.7%), and 2.2% (95% CI 0.2–4.3%), respectively. Patients with negative VIRSTA and negative TTE had an IE prevalence of 0.9% (95% CI 0–2.8%). Performing an echocardiogram was independently associated with lower 30-day mortality (OR 0.24 95% CI 0.10–0.54, p = 0.001). Conclusion: PREDICT and POSITIVE scores were not sufficient to rule out IE without TEE. In patients with negative VIRSTA score, it was doubtful if IE could be discarded with a negative TTE. Not performing an echocardiogram was associated with worse outcomes, which might be related to presence of occult IE. Further studies are needed to assess the usefulness of clinical prediction rules in avoiding echocardiographic evaluation in SAB patients.
    Keywords Staphylococcus aureus ; endocarditis ; clinical prediction rules ; echocardiography ; Medicine ; R
    Language English
    Publishing date 2022-03-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients

    Antonio F. Caballero Bermejo / Belén Ruiz-Antorán / Ana Fernández Cruz / Elena Diago Sempere / Alejandro Callejas Díaz / Elena Múñez Rubio / Cristina Avendaño-Solá / Antonio Ramos Martínez / Aránzazu Sancho López / Puerta de Hierro COVID-19 Study Group

    Trials, Vol 21, Iss 1, Pp 1-

    SARTRE: a structured summary of a study protocol for a randomised controlled trial

    2020  Volume 3

    Abstract: Abstract Objectives In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release. Elevated levels of blood IL-6 had been identified as a ...

    Abstract Abstract Objectives In some patients, acute, life-threatening respiratory injury produced by viruses such as SARS-CoV and other viral pneumonia are associated with an over-exuberant cytokine release. Elevated levels of blood IL-6 had been identified as a one of the risk factors associated with severe COVID-19 disease. Anti-IL6 inhibitors are among the therapeutic armamentarium for preventing the fatal consequences of acute respiratory and multi organ failure in around 20% of the COVID-19 infected patients. At present, their use is prioritized to patients with severe interstitial pneumonia (Brescia-COVID Scale-COVID 2-3) with hyperinflammation as determined by the presence of elevated IL6 and/or d-dimer, or progressive d-dimer increase, in patients who otherwise are subsidiary to ICU admission. However, many uncertainties remain on the actual role of anti-IL6 inhibitors in this setting, and whether current use and timing is the right one. There is the hypothesis that the use of anti-IL6 inhibitors at an earlier state during the hyperinflammatory syndrome would be beneficial and may avoid progressing to ARDS. On the other hand, the standard of care has changed and nowadays the use of corticosteroids has become part of the SOC in the treatment of COVID-19 pneumonia. Our limited experience suggests that better treatment outcomes can be achieved when combining IL6-inhibitors (e.g. sarilumab) with corticosteroids. The aim of the present study is to evaluate if an earlier therapeutic intervention with sarilumab plus SOC (including corticosteroids) may be more effective than current standard of care alone, in preventing progression to respiratory failure in COVID-19 infected patients with interstitial pneumonia. This study will also provide supportive evidence to that provided by currently ongoing studies on the efficacy and safety of sarilumab in this clinical context. Trial design A phase two multi-center randomised controlled trial (RCT) with two parallel arms (1:1 ratio). Participants They will be hospitalized ...
    Keywords COVID-19 ; SARS-CoV-2 ; Randomised controlled trial ; protocol ; sarilumab ; anti-IL6 inhibitor ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients

    Elena Diago-Sempere / José Luis Bueno / Aránzazu Sancho-López / Elena Múñez Rubio / Ferrán Torres / Rosa Malo de Molina / Ana Fernández-Cruz / Isabel Salcedo de Diego / Ana Velasco-Iglesias / Concepción Payares-Herrera / Inmaculada Casas Flecha / Cristina Avendaño-Solà / Rafael Duarte Palomino / Antonio Ramos-Martínez / Belén Ruiz-Antorán

    Trials, Vol 22, Iss 1, Pp 1-

    study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

    2021  Volume 14

    Abstract: Abstract Background COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with ... ...

    Abstract Abstract Background COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. Methods/design The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. Discussion This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. Trial registration ClinicalTrials.gov NCT04345523 . Registered on 30 March, 2020. First posted date: April 14, 2020.
    Keywords COVID-19 ; Randomized ; Controlled trial ; Protocol ; Convalescent plasma (CP) ; Antibodies ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Risk factors for Clostridium difficile diarrhea in patients with inflammatory bowel disease

    Antonio Ramos-Martínez / Jorge Ortiz-Balbuena / Isabel Curto-García / Ángel Asensio-Vegas / Rocío Martínez-Ruiz / Elena Múñez-Rubio / Mireia Cantero-Caballero / Isabel Sánchez-Romero / Irene González-Partida / María Isabel Vera-Mendoza

    Revista Espanola de Enfermedades Digestivas, Vol 107, Iss 1, Pp 4-

    2015  Volume 9

    Abstract: Background: Despite the growing incidence of Clostridium difficile diarrhea (CCD) in patients with inflammatory bowel disease (IBD), little is known about the associated risk factors. Method: A retrospective study comparing cases of CCD in patients with ... ...

    Abstract Background: Despite the growing incidence of Clostridium difficile diarrhea (CCD) in patients with inflammatory bowel disease (IBD), little is known about the associated risk factors. Method: A retrospective study comparing cases of CCD in patients with IBD to IBD carriers who did not develop CCD. A comparison was also made with patients who developed CCD but did not suffer IBD. Results: Three cases (20 %) with IBD and CCD had received antibiotics during the previous three months versus none of the controls (IBD without CCD, p = 0.22). Ten cases (67 %) received treatment with proton pump inhibitors (PPIs) versus 2 (13 %) in the control group (IBD without CCD, p = 0.001). Seven cases underwent colonoscopy and pseudomembranes were seen in one (14 %). Fourteen (93 %) patients demonstrated a favourable response to metronidazole. Patients with IBD and CCD presented with younger age (36 ± 10 years), a higher degree of community-acquired infection (13 patients, 87 %), immunosuppressive treatment (7 patients, 47 %) and less patients had received previous antibiotic treatment (3 patients, 20 %) than those with CCD without IBD. The proportion of patients who received treatment with PPIs was similar (66 % and 80 %, respectively p = 0.266). Conclusions: CCD in IBD carriers affects younger patients, the majority are community acquired (less nosocomial) and it is more related to previous treatment with PPIs than with the antibiotic treatment. Clinical evolution is also favourable.
    Keywords Clostridium difficile ; Enfermedad inflamatoria intestinal ; Colitis ulcerosa ; Enfermedad de Crohn ; Diarrea asociada a antibióticos ; Metronidazol ; Medicine ; R ; Internal medicine ; RC31-1245 ; Specialties of internal medicine ; RC581-951 ; Diseases of the digestive system. Gastroenterology ; RC799-869
    Subject code 610 ; 616
    Publishing date 2015-01-01T00:00:00Z
    Publisher The Spanish Society of Digestive Pathology
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Inappropriate antibiotic use in the COVID-19 era

    Jorge Calderón-Parra / Antonio Muiño-Miguez / Alejandro D Bendala-Estrada / Antonio Ramos-Martínez / Elena Muñez-Rubio / Eduardo Fernández Carracedo / Javier Tejada Montes / Manuel Rubio-Rivas / Francisco Arnalich-Fernandez / Jose Luis Beato Pérez / Jose Miguel García Bruñén / Esther Del Corral Beamonte / Paula Maria Pesqueira Fontan / Maria Del Mar Carmona / Rosa Fernández-Madera Martínez / Andrés González García / Cristina Salazar Mosteiro / Carlota Tuñón de Almeida / Julio González Moraleja /
    Francesco Deodati / María Dolores Martín Escalante / María Luisa Asensio Tomás / Ricardo Gómez Huelgas / José Manuel Casas Rojo / Jesús Millán Núñez-Cortés / SEMI-COVID-19 Network

    PLoS ONE, Vol 16, Iss 5, p e

    Factors associated with inappropriate prescribing and secondary complications. Analysis of the registry SEMI-COVID.

    2021  Volume 0251340

    Abstract: Background Most patients with COVID-19 receive antibiotics despite the fact that bacterial co-infections are rare. This can lead to increased complications, including antibacterial resistance. We aim to analyze risk factors for inappropriate antibiotic ... ...

    Abstract Background Most patients with COVID-19 receive antibiotics despite the fact that bacterial co-infections are rare. This can lead to increased complications, including antibacterial resistance. We aim to analyze risk factors for inappropriate antibiotic prescription in these patients and describe possible complications arising from their use. Methods The SEMI-COVID-19 Registry is a multicenter, retrospective patient cohort. Patients with antibiotic were divided into two groups according to appropriate or inappropriate prescription, depending on whether the patient fulfill any criteria for its use. Comparison was made by means of multilevel logistic regression analysis. Possible complications of antibiotic use were also identified. Results Out of 13,932 patients, 3047 (21.6%) were prescribed no antibiotics, 6116 (43.9%) were appropriately prescribed antibiotics, and 4769 (34.2%) were inappropriately prescribed antibiotics. The following were independent factors of inappropriate prescription: February-March 2020 admission (OR 1.54, 95%CI 1.18-2.00), age (OR 0.98, 95%CI 0.97-0.99), absence of comorbidity (OR 1.43, 95%CI 1.05-1.94), dry cough (OR 2.51, 95%CI 1.94-3.26), fever (OR 1.33, 95%CI 1.13-1.56), dyspnea (OR 1.31, 95%CI 1.04-1.69), flu-like symptoms (OR 2.70, 95%CI 1.75-4.17), and elevated C-reactive protein levels (OR 1.01 for each mg/L increase, 95% CI 1.00-1.01). Adverse drug reactions were more frequent in patients who received ANTIBIOTIC (4.9% vs 2.7%, p < .001). Conclusion The inappropriate use of antibiotics was very frequent in COVID-19 patients and entailed an increased risk of adverse reactions. It is crucial to define criteria for their use in these patients. Knowledge of the factors associated with inappropriate prescribing can be helpful.
    Keywords Medicine ; R ; Science ; Q
    Subject code 610
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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