Discussion
neutropenia, febrile neutropenia, fever, infections, transfusional
ACUTE MYELOID LEUKEMIA, NEUTROPENIA, FEBRILE NEUTROPENIA, CNS INFECTIONS, INFECTIONS, GRAM-NEGATIVE BACTERIAL INFECTIONS, DISEASES
The debate on the efficacy of FQ prophylaxis in the era of multidrug resistance is ongoing. Our study will contribute to this debate by comparing the efficacy and safety of ciprofloxacin with fosfomycin in a homogeneous population of patients treated at several centers with different prevalence in MRGNB.The supporters of FQ prophylaxis (either ciprofloxacin or levofloxacin) have reported an increase in the incidence of Gram-negative bacterial infections [The opponents of FQ prophylaxis argue that these drugs are associated with gut colonization by MRGNB. In hematological patients, gut colonization is associated with blood stream infections when neutropenia occurs [Our study will have some limitations: first it will be open, which might favor the early termination of prophylaxis in the fosfomycin arm. However, a strict definition of febrile neutropenia of infectious origin has been specified in the protocol, which excludes transfusional associated fever or fever related to cytarabine (a common chemotherapy drug used in acute myeloid leukemia) or other drugs. Second, this is not a superiority trial, but a non-inferiority one, because it would have been unethical to conduct a trial comparing fosfomycin with placebo. Notwithstanding the limitations of this type of design [In summary, the present project addresses an extremely important health problem by evaluating the efficacy of fosfomycin, a broad-spectrum antibiotic with a better safety profile and a lower potential of resistance induction than ciprofloxacin, in the prevention of infections in hematological patients with high-risk neutropenia. The battery of microbiological studies that will be carried out will allow us to evaluate prospectively, for the first time, the microbiological safety of both pharmacological strategies and the selection of MRGNB in each arm and will generate valuable information on the way in which changes that occur in the fecal microbiome of the patients throughout the treatment modify the evolution of the studied diseases.