Clara María Rosso-Fernández

Effectiveness of oral step-down therapy and early oral switch for bloodstream infections caused by Enterobacterales: A post hoc emulation trial of the SIMPLIFY trial

Emanuele Rando, Mercedes Delgado-Valverde, Josune Goikoetxea Aguirre, Laura Guío Carrión et autres

OBJECTIVES: We investigated the effectiveness of early oral switch for treating Enterobacterales bloodstream infection (BSI) by performing a post hoc emulation trial of the SIMPLIFY trial. METHODS: We conducted a post hoc analysis of a randomized controlled trial. We specified the target …

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Efficacy of clozapine versus standard treatment in adult individuals with intellectual disability and treatment-resistant psychosis (CLOZAID): study protocol of a multicenter randomized clinical trial

María Alemany-Navarro, Bianca Sánchez-Barbero, Pablo Reguera‐Pozuelo, Laura Altea-Manzano et autres

Background Intellectual disability (ID) affects approximately 1% of the worldwide population and individuals with ID have a higher comorbidity with mental illness, and specifically psychotic disorders. Unfortunately, among individuals with ID, limited research has been conducted since ID individuals are usually excluded …

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Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Elena Zapata‐Arriaza, Manuel Medina-Rodríguez, Francisco Moniche Álvarez, Asier de Albóniga-Chindurza et autres

RATIONALE: In-stent reocclusion after endovascular therapy has a negative impact on outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Optimal antiplatelet therapy approach in these patients to avoid in-stent reocclusion is yet to be elucidated. AIMS: To assess efficacy …

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Efficacy and safety of a structured de-escalation from antipseudomonal β-lactams in bloodstream infections due to Enterobacterales (SIMPLIFY): an open-label, multicentre, randomised trial

Luis Eduardo López-Cortés, Mercedes Delgado-Valverde, Elisa Moreno-Mellado, Josune Goikoetxea Aguirre et autres

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Additional file 1 of Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Elena Zapata‐Arriaza, Manuel Medina-Rodríguez, Francisco Moniche Álvarez, Marta Aguilar Pérez et autres

Additional file 1: Supplementary Material 1. Minor Revision. Supplementary Material 2. DSMB. Supplementary Material 3. Full protocol.

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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

Natalia Andrea Maldonado, Clara María Rosso-Fernández, Inés Portillo-Calderón, Irene Borreguero et autres

Introduction Enterococcus spp is responsible for 8%–15% of total bacteraemias with an associated global mortality around 23%–30%. Regarding the clinical management of enterococcal bacteraemia, the evidence on the duration of antibiotic treatment is scarce and the studies do not discriminate between complicated …

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P1264: A PREDEFINED STRATEGY AIMED TO REDUCE ANTIBIOTIC EXPOSURE OF SCT RECIPIENTS PRESERVES DIVERSITY AND COMPOSITION OF INTESTINAL MICROBIOTA AND REDUCES THE INCIDENCE OF ACUTE-GVHD WITHOUT SIDE EFFECTS

Ildefonso Espigado, Nancy Rodríguez-Torres, Silvia Jiménez‐Jorge, Lucrecia Yáñez Sansegundo et autres

Topic: 22. Stem cell transplantation - Clinical Background: intestinal microbiota (iMB) composition and alfa-diversity may influence incidence and severity of aGvHD after allo-SCT; antibiotherapy (anti-B) damages iMB reducing its diversity. Aims: to investigate the effect of two (centers driven) predefined antibiotic strategies …

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Efficacy and safety of different antimicrobial DURATions for the treatment of Infections associated with Osteosynthesis Material implanted after long bone fractures (DURATIOM): Protocol for a randomized, pragmatic trial

Carmen Garrigós, Clara María Rosso-Fernández, Irene Borreguero, Patricia Rodríguez et autres

BACKGROUND: Infection associated with osteosynthesis material (IOM) is one of the most feared and challenging complications of trauma surgery and can cause significant functional loss, requiring multiple interventions and excessive consumption of antimicrobials. Evidence is needed about the best surgical procedure and …

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Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial

Álvaro Giráldez Gallego, Elisa Rodríguez‐Seguel, R Valencia, Áurea Morillo-García et autres

OBJECTIVE: We aimed to compare the response rates between two different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first three 40 µg doses (month 0-1-2), and identify factors associated with the final response. DESIGN: A total …

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Effectiveness and Safety of a Structured De-Escalation from Antipseudomonal Β-Lactams in Bloodstream Infections Due to Enterobacterales: A Multicentre Randomised Clinical Trial (SIMPLIFY)

Luis Eduardo López-Cortés, Mercedes Delgado-Valverde, Elisa Moreno Mellado, Ane Josune Goikoetxea et autres

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Safety and efficacy of tirofiban in acute ischemic stroke due to tandem lesions undergoing mechanical thrombectomy: A multicenter randomized clinical trial (ATILA) protocol

Manuel Medina-Rodríguez, Francisco Moniche, Asier de Albóniga-Chindurza, Joaquín Ortega-Quintanilla et autres

Background: In-stent thrombosis after mechanical thrombectomy (MT) worsen outcomes in acute ischemic stroke (AIS) due to tandem lesions (TL). Although an optimal antiplatelet therapy is needed, the best approach to avoid in-stent thrombosis is yet to be elucidated. Hypothesis: Low-dose intravenous tirofiban …

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Study protocol for a randomized clinical trial to assess 7 versus 14-days of treatment for Pseudomonas aeruginosa bloodstream infections (SHORTEN-2 trial)

José Molina, Clara María Rosso-Fernández, Enrique Montero-Mateos, José Ramón Paño‐Pardo et autres

BACKGROUND: Research priorities in Antimicrobial Stewardship (AMS) have rapidly evolved in the last decade. The need for a more efficient use of antimicrobials have fueled plenty of studies to define the optimal duration for antibiotic treatments, and yet, there still are large …

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