Eficacia y seguridad de 7 versus 14 días de tratamiento antibiótico para la bacteriemia producida por Pseudomonas aeruginosa: un ensayo clínico multicéntrico, aleatorizado (SHORTEN-2) con un análisis DOOR/RADAR.

Datos básicos

Protocolo:: SHORTENII
EUDRACT:: 2021-003847-10
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:: 2022
Año de finalización:

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Determinar si un régimen de tratamiento antibiótico de 7 días es superior a un régimen de 14 días en el tratamiento de bacteriemia por P. aeruginosa, evaluando de manera integrada tanto la efectividad del régimen corto como su potencial para reducir la exposición a antibióticos y los acontecimientos adversos graves. Objetivos Secundarios: 1. Determinar si el régimen corto es no inferior al régimen prolongado en términos de recurrencia de infección y mortalidad, y si se puede aplicar de forma segura a nivel individual utilizando una regla de decisión clínica simple. 2. Describir los efectos adversos y sobreinfecciones, específicamente los producidos por bacterias multirresistentes y Clostridioides difficile en ambos regímenes de tratamiento. 3. Analizar la eficiencia de los regímenes cortos en cuanto al número de días de estancia hospitalaria evitados y su coste directo al final del período de seguimiento. 4. Confirmar la recurrencia de infecciones mediante secuenciación en los aislamientos de P. aeruginosa que ocurran durante el seguimiento. 5. Comparar el efecto de los regímenes de tratamiento corto y prolongado sobre la preservación de la diversidad de la microbiota intestinal.

Documentos

No hay documentos

Participantes

María Martín Cerezuela

Data Manager / Study Coordinator
Mónica Gordón Sahuquillo

Investigador Colaborador
Eva María González Barberá

Investigador Colaborador
Esther Villarreal Tello

Investigador Colaborador
Juan Salvador Frasquet Artes

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Paula Ramírez Galleymore

Investigador Principal
Marta García Revaliente

Data Manager / Study Coordinator

Grupos

Infecciones Respiratorias

Investigador Principal

Raúl Méndez Ocaña
Infección Grave

Investigador Principal

María Ángeles Tormo Mas
Medicina Intensiva

Leader

Álvaro Castellanos Ortega
Farmacogenética

Investigador Principal

María José Herrero Cervera
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SALUD DE SEVILLA

Resultados del Ensayo Clínico

Publicaciones en Revistas 74

[Translated article] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence

Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda

Editorial Material. 10.1016/j.farma.2024.08.009. 2024

[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Andrés JLP, Solsona MDE

Article. 10.1016/j.farma.2023.10.004. 2024

[Translated article] National registry and analysis of pharmaceutical interventions in critical care units: PHARMACRITIC study.

Cerezuela, Maria Martin; (...); Chiva, Esther Domingo

Article. 10.1016/j.farma.2024.10.003. 2024

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

Antimicrobial Pharmacokinetics and Pharmacodynamics in Critical Care: Adjusting the Dose in Extracorporeal Circulation and to Prevent the Genesis of Multiresistant Bacteria.

Ruiz-Ramos, Jesus, Gras-Martin, Laura, Ramirez, Paula

Article. 10.3390/antibiotics12030475. 2023

Antimicrobial stewardship in hospitals: Expert recommendation guidance document for activities in specific populations, syndromes and other aspects (PROA-2) from SEIMC, SEFH, SEMPSPGS, SEMICYUC and SEIP.

Cercenado, Emilia; (...); Retamar-Gentil, Pilar

Practice Guideline. 10.1016/j.eimce.2022.05.013. 2023

Antimicrobial stewardship in hospitals: Expert recommendation guidance document for activities in specific populations, syndromes and other aspects (PROA-2) from SEIMC, SEFH, SEMPSPGS, SEMICYUC and SEIP

Cercenado, Emilia; (...); Retamar-Gentil, Pilar

Editorial Material. 10.1016/j.eimc.2022.05.005. 2023

Antimicrobial stewardship programs in the intensive care unit in patients with infections caused by multidrug-resistant gram-negative bacilli

Ramos, J. Ruiz, Galleymore, P. Ramirez

Article. 10.1016/j.medin.2022.07.007. 2023

Antimicrobial stewardship programs in the Intensive Care Unit in patients with infections caused by multidrug-resistant Gram-negative bacilli.

Ruiz-Ramos J, Ramírez P

Article. 10.1016/j.medine.2022.09.004. 2022

Clinical characteristics, risk factors and management of patients with inflammatory bowel disease and hidradenitis suppurativa: a nationwide multicenter study of the GETECCU ENEIDA registry

Madero Velazquez, L.; (...); Gutierrez-Casbas, A.

Meeting Abstract. 2024

CMV REACTIVATIONS IN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT FROM HLA-MATCHED AND HAPLOIDENTICAL DONORS WITH POST-TRANSPLANT CYCLOPHOSPHAMIDE.

Chorão P; (...); Sanz J

Article. 10.1016/j.jtct.2024.01.082. 2024

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

Cytomegalovirus DNAemia in hematological patients undergoing CD19-directed CAR-T cell therapy: should it be systematically monitored?

Solano de la Asuncion, Carlos; (...); Navarro, David

Letter. 10.1016/j.cmi.2023.05.010. 2023

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

Impact of the "Zero Resistance" program on acquisition of multidrug-resistant bacteria in patients admitted to Intensive Care Units in Spain. A prospective, intervention, multimodal, multicenter study.

Álvarez-Lerma F; (...); Martínez-Alonso M

Article. 10.1016/j.medine.2022.12.002. 2023

Impact of the ?Zero Resistance? program on acquisition of multidrug-resistant bacteria in patients admitted to Intensive Care Units in Spain. A prospective, intervention, multimodal, multicenter study

Alvarez-Lerma, Francisco; (...); Martinez-Alonso, Montserrat

Article. 10.1016/j.medin.2022.12.002. 2023

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

Live donor kidney transplantation. Situation analysis and roadmap.

de la Oliva Valentín M; (...); Domínguez-Gil B

Article. 10.1016/j.nefroe.2022.02.002. 2022

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

Pharmacist care in hospital emergency departments: a consensus paper from the Spanish hospital pharmacy and emergency medicine associations

Ramos, Jesus Ruiz; (...); Marco, Javier Povar

Article. 2023

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

Severe community-acquired Streptococcus pneumoniae bacterial meningitis: clinical and prognostic picture from the intensive care unit.

Martín-Cerezuela M; (...); Ramírez-Galleymore P

Article. 10.1186/s13054-023-04347-3. 2023

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

Switching from immediate- to extended-release cysteamine in patients with nephropathic cystinosis: from clinical trials to clinical practice.

Ariceta G; (...); Vara J

Article. 10.1093/ckj/sfae049. 2024

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024

Transcriptomics reveals shared immunosuppressive landscapes in ventilator-associated lower respiratory tract infections (VA-LRTI) patients.

Martin-Loeches I; (...); Bermejo-Martín JF

Article. 10.1080/14787210.2023.2256979. 2023

Treatment of critically ill patients with cefiderocol for infections caused by multidrug-resistant pathogens: review of the evidence.

Viale, Pierluigi; (...); Lodise, Thomas P.

Article. 10.1186/s13613-023-01146-5. 2023

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023