Eligibility criteria {10}
tumor, neoplasia, psychiatric illness, Fever of infectious, infection, leukemic infiltration, mucositis, neoplasm, allogeneic hematopoietic progenitor transplant, Hematopoietic Comorbidity, acute leukemia
TUMOR, NEOPLASIA, LIVER, HYPERSENSITIVITY, INFECTION, MUCOSITIS, NEOPLASM, ONCOLOGY, ACUTE LEUKEMIA
Candidate selection will be performed in 2 different settings depending on the therapeutic procedure:In subjects with a suspected diagnosis of acute leukemia, where the diagnosis of the neoplasm is made as an inpatient, the selection will take place once the diagnosis has been confirmed and prior to the start of intensive chemotherapy.In HSCT recipients, selection will take place on an outpatient basis during the pre-transplant evaluation.
Subjects must meet all of the following inclusion criteria:
Subjects must be able to understand the study procedures, comply with them, and give written informed consent prior to any specific study procedure.Adult subjects 18 years of age who meet one of the following criteria:
Diagnosis of acute leukemia who are to receive a first course of intensive chemotherapy orCandidates to receive a first allogeneic hematopoietic progenitor transplant with myeloablative conditioning orCandidates to receive a first allogeneic hematopoietic progenitor transplant with reduced-intensity conditioning* or an autologous hematopoietic progenitor transplant provided that at least one of the following risk factors for infection is present: Performance status (Eastern Cooperative Oncology Group, ECOG) ≥ 2. Expected grade 3–4 mucositis. Age ≥ 65 years. Hematopoietic Comorbidity Transplant Index (HCTI) ≥ 3. Serum albumin < 35 g/L. Active or refractory neoplasia at the time of stem cell transplantation. Total dose of etoposide > 500 mg/m. Total dose of cytarabine > 1 g/m.
Performance status (Eastern Cooperative Oncology Group, ECOG) 0 to 3.Adequate organ function defined as:Liver: bilirubin, alkaline phosphatase, or SGOT < 3 times the upper limit of normal (unless attributable to tumor activity)Renal: creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless attributable to leukemic infiltration)
Life expectancy greater than 3 monthsWomen of childbearing age must not be pregnant or breastfeeding and must have a negative pregnancy test at the time of screening. Women of childbearing age and men with female partners of childbearing age must agree to practice 2 highly effective contraceptive measures and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completion of treatment.
Patients who meet any of the following exclusion criteria cannot be included in this study:
Hypersensitivity to fluoroquinolones or fosfomycin.Treatment with broad-spectrum antimicrobial therapy within 4 weeks of the first study treatment.Intensive chemotherapy or prior hematopoietic stem cell transplantation. Treatment with hydroxyurea or corticosteroids used to control white blood cell count is allowed.Fever of infectious origin or documented infection within 4 weeks of the first study treatment.Presence of any serious psychiatric illness or physical condition that, in the judgment of the physicians, contraindicates the patient’s inclusion in the clinical trial.