SAFEStopping Antibiotics After 3 Days for the Treatment of FEbrile Neutropenia in Haematology Patients (SAFE Study): a Randomized Open-label Non-inferiority Trial
Comparison short vs extended EBAT treatment group
Agranulocitosis+8
+ Citopenia
+ Enfermedades hemáticas y linfáticas
Estudio de Cuidados de Apoyo
Resumen
Fecha de inicio: 26 de febrero de 2024
Fecha en la que se inscribió al primer participante.The goal of this clinical trial is to compare a short course of antibiotics in patients in whom no bacterial infection is found with the current "golden standard": long-term antibiotic treatment in adult hematology patients who develop neutropenic fever. The main question it aims to answer is: whether the short-term treatment is equally safe for patients, hence the name 'SAFE study'. Participants will be randomly assigned (randomized) to one of two treatment options once they develop neutropenic fever: short-term or long-term antibiotic treatment. An additional blood sample, urine sample and stool sample will be collected. Researchers will compare the short-term and the long-term antibiotic treatment groups to see if the short treatment is equally safe as the long-term treatment group.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 410 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Cuidados de Apoyo
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 16 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; * Age older than 16 years; * Intensive therapy is started within three days before randomization for one of the following haematological conditions: * Remission induction chemotherapy for newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); OR * Re-induction chemotherapy for relapsed after haematological remission lasting for a minimum duration of 6 months; OR * Conditioning regimen to prepare for an allogeneic HCT; OR * Conditioning regimen to prepare for an autologous HCT. * Expected longstanding (≥ 7 days) neutropenia (ANC \< 0.5x10\^9/L); * Expected length of hospital stay of at least 10 days. Exclusion Criteria: 1. Clinically or microbiologically documented infection; 2. Patient already receives broad spectrum antibiotic therapy; 3. Any critical illness for which Intensive Care Unit treatment is required; 4. SOFA score ≥ 11; 5. Longstanding neutropenia (\>21 days) prior inclusion; 6. Previous enrolment in this study; 7. Not able to provide written informed consent; 8. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol; 9. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación