Randomized phase 3 trial to compare efficacy and safety of oral fosfomycin versus ciprofloxacin to prevent febrile neutropenia in patients with acute leukemia or recipients of hematopoietic stem cell transplant.
Multicenter, prospective, randomized, open label phase III trial to assess the efficacy and safety of oral fosfomycin vs. oral ciprofloxacin in the prevention of febrile neutropenia in patients with acute leukemia who are treated with intensive chemotherapy and/or are recipients of a hematopoietic stem cell transplant. Non-inferiority design. 156 patients will be recruited: 78 in each arm
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
156
Oral fosfomycin, three times daily, starting from the first day of induction chemotherapy or conditioning until absolute neutrophil count \>0,5x109/L.
Instituto de Investigación Sanitaria del Principado de Asturias
Oviedo, Principality of Asturias, Spain
RECRUITINGFebrile neutropenia of infectious origin
Febrile neutropenia that requires antibacterial treatment.
Time frame: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum
Documented infections
Rate and type of documented infections
Time frame: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum
Use of broad spectrum antibiotics
Index of days of antibiotics per hospitalization days. Antibiotics will be classified according the Watch/Reserve classification
Time frame: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum
Overall survival
Time frame: Time from the day of randomization to the date of death, whatever the cause of death, up to 12 weeks.
Drug related adverse events
Incidence of Adverse Events (AE), severity and type of AEs.
Time frame: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum
Evolution of resistome
Rate of patients colonized by multidrug resistant bacteria as determined by metagenomic sequencing
Time frame: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum
Microbiome evolution
Changes in the gut microbiome produced under both prophylactic strategies during the study period.
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Time frame: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum
Microbiological safety
Rate of patients colonized by multidrug resistant bacteria as determined by surveillance cultures
Time frame: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum