Portal de investigación
- Inicio
- Proyectos y Estudios
- Ensayo clínico multicéntrico, aleatorizado, controlado con placebo y de grupos paralelos para evaluar la eficacia de DAV132 en la prevención de la infección por Clostridioides difficile en pacientes con leucemia mieloide aguda o síndrome mielodisplásico de alto riesgo de diagnóstico reciente tratados con quimioterapia intensiva.
Ensayo clínico multicéntrico, aleatorizado, controlado con placebo y de grupos paralelos para evaluar la eficacia de DAV132 en la prevención de la infección por Clostridioides difficile en pacientes con leucemia mieloide aguda o síndrome mielodisplásico de alto riesgo de diagnóstico reciente tratados con quimioterapia intensiva.
Datos básicos
- Código:
- DAV132-CL-3001
- Protocolo:
- DAV132-CL-3001
- EUDRACT:
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2021
- Año de finalización:
- 2026
Documentos
- No hay documentos
Participantes
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[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
A High Percentage of DNAM-1+and Low Percentage of Tactile plus NK Cells at Diagnosis Correlate with Complete Response and Survival in AML: A Sub-Analysis of the Ven-a-Qui Pethema Trial
Bergua Burgues, Juan Miguel; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2023-189676. 2023
A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain
Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro
Article. 10.33393/grhta.2022.2333. 2022
A multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A Study of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, for Patients with Frontline and Relapsed/Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Pemmaraju, Naveen; (...); Daver, Naval
Meeting Abstract. 10.1182/blood-2021-146681. 2021
Actinotignum schaalii infection: Challenges in diagnosis and treatment.
Sahuquillo-Arce JM; (...); López-Hontangas JL
Article. 10.1016/j.heliyon.2024.e28589. 2024
Acute leukemia arising from myeloproliferative or myelodysplastic/myeloproliferative neoplasms: A series of 372 patients from the PETHEMA AML registry.
Hernandez-Boluda, Juan-Carlos; (...); PETHEMA group
Article. 10.1016/j.leukres.2022.106821. 2022
Analysis of chemical contamination by hazardous drugs with BD HD Check(R) system in a tertiary hospital
Valero García S; (...); Poveda Andrés JL
Article. 10.1177/10781552211038518. 2021
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Azacitidine or Decitabine Monotherapy for the Treatment of AML: A Comparative Systematic Review and Meta-Analysis
Saiz-Rodriguez, M; (...); Montesinos, P
Meeting Abstract. 2021
Azacitidine vs. Decitabine in Unfit Newly Diagnosed Acute Myeloid Leukemia Patients: Results from the PETHEMA Registry
Labrador J; (...); Montesinos P
Article. 10.3390/cancers14092342. 2022
Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.
Iglesias Gómez R; (...); Poveda Andrés JL
Article. 10.1136/ejhpharm-2021-002741. 2021
Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.
Fernandez Rivera C; (...); Hernandez D
Article. 10.1111/ctr.14550. 2022
Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients
Megias-Vericat, JE; (...); Poveda, JL
Article. 10.1016/j.thromres.2021.07.009. 2021
Clonal Evolution Analysis Using Next Generation Sequencing (NGS) Panel in a Cohort of 3,025 Patients With Acute Myeloid Leukemia (AML)
Colmenares, Rafael; (...); Montesinos, Pau
Meeting Abstract. 2023
Comparison of the 2022 and 2017 European LeukemiaNet risk classifications in a real-life cohort of the PETHEMA group
Sargas, Claudia; (...); Montesinos, Pau
Article. 10.1038/s41408-023-00835-5. 2023
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
Conventional PCR Versus Next Generation Sequencing for Diagnosis of FLT3, IDH and NPM1 Mutations in Acute Myeloid Leukemia: Interim Analysis of the PCR-LMA Protocol of the Pethema Group
Boluda, Blanca; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2022-160136. 2022
Characteristics and Outcome of Patients with Acute Myeloid Leukemia and Trisomy 4
Kayser, Sabine; (...); Schlenk, Richard F.
Meeting Abstract. 10.1182/blood-2021-150281. 2021
Characteristics and outcome of patients with acute myeloid leukemia and trisomy 4.
Kayser, Sabine; (...); Schlenk, Richard F.
Meeting Abstract. 10.3324/haematol.2022.281137. 2022
Characteristics and Outcomes of Adult Patients in the PETHEMA Registry with Relapsed or Refractory FLT3-ITD Mutation-Positive Acute Myeloid Leukemia.
Martinez-Cuadron, David; (...); On Behalf Of The Pethema Group
Article. 10.3390/cancers14112817. 2022
Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.
Salinas P; (...); Escaned J
Article. 10.1016/j.carrev.2021.11.015. 2021
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
EFFECTIVENESS AND TOXICITY OF THE USE OF INOTUZUMAB (INO) IN PATIENTS WITH RESISTANT OR RECALLING (R/R) ACUTE LYMPHOBLASTIC LEUKEMIA (LAL). STUDY OF PATIENTS INCLUDED IN INO'S EXPANDED USE PROGRAM
Ribera Santasusana, J. M.; (...); Valero, M.
Meeting Abstract. 2021
Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment
Palanques-Pastor T; (...); Poveda Andrés JL
Article. 10.1159/000517813. 2021
Evaluating the diagnostic performance of Liaison® chemiluminescence assay as screening tool for detection of acute Epstein-Barr infection: A comparative study
Tortosa-Carreres, Jordi; (...); Lopez-Hontangas, Jose Luis
Article. 10.1016/j.diagmicrobio.2023.116167. 2024
Evolution of the Genetic and Biological Studies Performed at Diagnosis in Patients with Acute Myeloid Leukemia Included in the Pethema Epidemiological Registry (REALMOL Study)
Labrador, Jorge; (...); Manuel Alonso-Dominguez, Juan
Meeting Abstract. 10.1182/blood-2022-163016. 2022
Experience with IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate (ADC), in Frontline Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Pemmaraju, Naveen; (...); Daver, Naval
Meeting Abstract. 10.1182/blood-2021-146666. 2021
Exploring Potential Molecular Mechanisms of Drug Response in FLT3-ITD Negative AML Patients Treated with Quizartinib Vs Placebo Plus Standard Chemotherapy in the Quiwi Trial
Mosquera Orgueira, Adrian; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2023-180710. 2023
FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients-efficacy and microbiologic safety
Moreno, Ainhoa Fernandez; (...); Bernal, Teresa
Article. 10.1186/s13063-023-07702-5. 2023
Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.
Plaza J; (...); Moret-Tatay I
Article. 10.3390/ijms25073717. 2024
Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis
Editorial Material. 2022
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
High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.
El-Qutob D; (...); Carrera-Hueso FJ
Article. 10.1016/j.hrtlng.2022.02.003. 2022
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
Hospitalization budget impact during the COVID-19 pandemic in Spain.
Carrera-Hueso, F. J.; (...); Crespo-Palomo, C.
Article. 10.1186/s13561-021-00340-0. 2021
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Iadademstat in Combination with Azacitidine Generates Robust and Long Lasting Responses in AML Patients (ALICE Trial)
Salamero, Olga; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2021-152183. 2021
Idasanutlin Plus Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia: Results of the MIRROS Trial.
Konopleva, Marina Y.; (...); Wei, Andrew H.
Article. 10.1182/bloodadvances.2021006303. 2022
IgG antibody response to pneumococcal-conjugated vaccine (Prevenar®13) in children with immunodeficiency disorders.
Garrido-Jareño M; (...); Pemán-García J
Article. 10.1007/s00430-022-00759-0. 2023
Impact of FLT3-ITD Mutation Status and Its Ratio in a Cohort of 2901 Patients Undergoing Upfront Intensive Chemotherapy: A PETHEMA Registry Study.
Ayala, Rosa; (...); Montesinos, Pau
Article. 10.3390/cancers14235799. 2022
Impact of Long-COVID on Health Care Burden: A Case Control Study
Valdivieso-Martinez, Bernardo; (...); Redon, Josep
Article. 10.3390/jcm12185768. 2023
Impact of trisomy 19 on outcome according to genetic makeup in patients with acute myeloid leukemia.
Kayser, Sabine; (...); Schlenk, Richard F.
Article. 10.3324/haematol.2022.282127. 2023
Incidence and Risk Factors for Development of Cardiac Toxicity in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia
Boluda, Blanca; (...); Montesinos, Pau
Article. 10.3390/cancers15082267. 2023
Indolent Acute Myeloid Leukemia with Long Survival in Patients Treated with Best Supportive Care Only: A Pethema Registry Study
Labrador, Jorge; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2022-162591. 2022
Interim Results from Clevo: A Non-Interventional Cohort Study Investigating the Clonal Evolution of FMS-like Tyrosine Kinase 3 (FLT3) Mutations during Disease Progression in Patients with Acute Myeloid Leukemia
Papayannidis, Cristina; (...); Vyas, Paresh
Meeting Abstract. 10.1182/blood-2022-156296. 2022
Invasive scedosporiosis in lung transplant recipients: A nine-year retrospective study in a tertiary care hospital.
Ibáñez-Martínez E; (...); Pemán J
Case Reports. 10.1016/j.riam.2021.06.002. 2021
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
ladademstat Combination with Azacitidine Is a Safe and Effective Treatment in First Line Acute Myeloid Leukemia. Final Results of the Alice Trial
Salamero, Olga; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2022-168945. 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
Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A
Bonanad, S; (...); Santos, S
Article. 10.1007/s12325-021-01853-0. 2021
Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Article. 10.3390/cancers14030596. 2022
Molecular Landscape and Validation of New Genomic Classification in 2668 Adult AML Patients: Real Life Data from the PETHEMA Registry.
Sargas, Claudia; (...); On Behalf Of Pethema Group
Article. 10.3390/cancers15020438. 2023
Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments
Gomez-Cebrian, N; (...); Pineda-Lucena, A
Review. 10.3390/cancers13184544. 2021
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
No Evidence that CD33 rs12459419 Polymorphism Predicts Gemtuzumab Ozogamicin Response in Consolidation Treatment of Acute Myeloid Leukemia Patients: Experience of the PETHEMA Group.
Castano-Bonilla, Tamara; (...); Montesinos, Pau
Article. 10.1155/2022/3132941. 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
Outcomes after intensive chemotherapy for secondary and myeloid-related changes acute myeloid leukemia patients aged 60 to 75 years old: a retrospective analysis from the PETHEMA registry
Martinez-Cuadron, David; (...); Montesinos, Pau
Article. 10.3324/haematol.2022.282506. 2024
Outcomes and prognostic factors of adults with refractory or relapsed T-cell acute lymphoblastic leukemia included in measurable residual disease-oriented trials
Ribera, JM; (...); PETHEMA Grp
Article. 10.1002/hon.2910. 2021
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Correction. 10.3389/fped.2021.834454. 2022
Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project
Morillo-Verdugo, R; (...); Diaz-Olmo, J
Article. 10.7399/fh.11719. 2021
Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.
Morillo-Verdugo R; (...); Díaz-Olmo J
Article. 2021
Pethema NGS-AML Project. Final Analysis and Clinical Validation of New Genomic Classifications
Sargas, Claudia; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2022-166639. 2022
Pharmacometabolomics by NMR in Oncology: A Systematic Review.
Gómez-Cebrián N; (...); Pineda-Lucena A
Article. 10.3390/ph14101015. 2021
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
Population-based sequencing of Mycobacterium tuberculosis reveals how current population dynamics are shaped by past epidemics.
Cancino-Munoz, Irving; (...); Comas, Inaki
Article. 10.7554/eLife.76605. 2022
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
Prognostic Impact of NPM1 and FLT3-ITD Mutations in Patients Treated with Non-Intensive Regimens: A Pethema Registry Study
Uriel Suarez, Edwin; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2022-167365. 2022
Prognostic significance of FLT3-ITD length in AML patients treated with intensive regimens.
Castaño-Bonilla T; (...); Montesinos, P
Article. 10.1038/s41598-021-00050-x. 2021
Role of the first WHO mutation catalogue in the diagnosis of antibiotic resistance in Mycobacterium tuberculosis in the Valencia Region, Spain: a retrospective genomic analysis.
Garcia-Marin, Ana Maria; (...); Comas, Inaki
Article. 10.1016/S2666-5247(23)00252-5. 2024
Sleep Duration and Cutaneous Melanoma Aggressiveness. A Prospective Observational Study in 443 Patients.
Gómez Olivas JD; (...); Martinez-García MA
Case Reports. 10.1016/j.arbr.2020.10.017. 2021
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
Spanish Society of Hematology and Hemotherapy expert consensus opinion for SARS-CoV-2 vaccination in onco-hematological patients.
Pinana, JL; (...); Bosch F
Article. 10.1080/10428194.2021.1992619. 2021
Starkeya nomas sp. nov., a prosthecate and budding bacterium isolated from an immunocompromized patient.
Sahuquillo-Arce JM; (...); López-Hontangas JL
Article. 10.1099/ijsem.0.005805. 2023
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 2022
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
The first wave of the COVID-19 epidemic in Spain was associated with early introductions and fast spread of a dominating genetic variant
Lopez, Mariana G.; (...); SeqCOVID-Spain Consortium
Article. 10.1038/s41588-021-00936-6. 2021
The FLT3-like Gene Expression Signature Predicts Response to Quizartinib in Wild-Type FLT3 Acute Myeloid Leukemia: An Analysis of the Pethema Quiwi Trial
Mosquera Orgueira, Adrian; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2023-180482. 2023
Treatment Outcomes in Unfit Patients with Newly Acute Myeloid Leukemia According to IDH1 Mutational Status: Real World Evidence from the Pethema Epidemiologic Registry
Martinez-Cuadron, David; (...); Montesinos, Pau
Meeting Abstract. 10.1182/blood-2023-189800. 2023
Treatment patterns and outcomes of 2310 patients with secondary acute myeloid leukemia: a PETHEMA registry study.
Martínez-Cuadrón D; (...); Montesinos P
Article. 10.1182/bloodadvances.2021005335. 2022
Use of Azacitidine or Decitabine for the Up-Front Setting in Acute Myeloid Leukaemia: A Systematic Review and Meta-Analysis.
Saiz-Rodriguez, M; (...); Montesinos, P
Article. 10.3390/cancers13225677. 2021
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