Studio Prospettico Sulle Batteriemie Febbrili Nei Pazienti Oncoematologici Pediatrici

Bacterial infections are the most frequent cause of infectious morbidity and mortality in the patient undergoing chemotherapy or hemopoietic stem cell transplantation (TCSE). The main predisposing factor is the impairment of innate immunity as a result of the alteration of mucous barriers (mucositis/enteritis from chemotherapy or radiotherapy), skin (CVC) and neutropenia (non-specific haematological toxicity due to chemotherapy or radiotherapy on bones with hemopoietic marrow). The most frequent form of infection is represented by fever whose cause remains indeterminate in 60-80% of cases. In about 10-15% of cases fever is accompanied by the positivization of hemoculture and is configured as a microbiologically determined infection (IMD). In the remaining cases, infectious episodes may be clinically documented such as pneumonia or bronchitis confirmed for radiological examination or CT scans, without the identification of the causative agent; these are defined as clinically determined infections (ICDs).

The knowledge, through hemoculture, of the germs responsible for febrile batteries over a given period of time, allows the definition of the predominant typology of germs responsible for systemic infection. On this basis, it is used to define the empirical antibiotic treatment that is given to the patient within a few hours of the onset of fever. Empirical antibiotic therapy must be effective with regard to the germs most represented in the department or in the area in question. Once the result of hemoculture has been received, usually within 48-72 hours, empirical antibiotic therapy can be maintained or modified in relation to the type of isolated germ and its susceptibility to antibiotics included in the empirical scheme. In fact, there is ample evidence that ready-to-treat with broad-spectrum antibiotics reduces mortality from bacterial infection in the immunocompromised patient, so this procedure is now a recommended approach by the guidelines. In addition to the knowledge of prevalent bacterial epidemiology for a certain type of immunocompromised patients in a given geographical area, a second tool capable of allowing appropriate empirical antibiotic therapy is the choice of therapy based on the presence or not of asymptomatic bacterial colonization of the patient. In fact, it is estimated that in 20-30% of cases the colonizing germ can become the cause of a batteriemia, facilitated by favoring factors such as the rupture of skin-mucous reefs or the appearance of neutropenia. The need to start empirical antibiotic therapy with effective molecules against causal germ (appropriate empirical therapy) has been shown to reduce bacterial infectious mortality at a time when antibiotic resistance is gradually increasing. It has been shown that inappropriate empirical antibiotic therapy, based on antibiotics to which the germ is not sensitive, is associated with increased infectious mortality from sepsis and septic shock. Among the adjuvant therapies used in immunosuppressed patients, in addition to antibiotic therapy, especially in patients with septic shock, there is the administration of opsonizing immunoglobulins and able to activate the complement such as, for example, immunoglobulins enriched in IgM. This practice is generally more established in immunocompetent patients while there are no prospective data in immunocompromised patients.

Primary objective Incidence of febrile batteries from antibiotic-resistant gram negative germs (MDR)

Secondary objectives Incidence of batteries from negative Gram germs; Incidence of batteries from gram positive germs; Incidence of fungemie; Incidence of septic shock; Incidence of batteries from colonising germs; Incidence of resistance to the main classes of antibiotics used empirically: cephalosporins of 3 and 4 generation (ceftazidime, cefipime), semisitical penicillins (piperacillin/tazobactam), carbapenemas (meropenem, imipenem), aminoglycosides (aminoglycosides (aikacin), second generation fluorquinolones; Response to empirical antibiotic therapy within 72 hours, without modification of empirical antibiotic therapy and without the use of Pentablobin; Response to empirical antibiotic therapy within 72 hours with the use of Pentaglobin within 72 hours of the onset of fever; Response to empirical antibiotic therapy with modification of the antibiotic (without the addition of antifungal), without the use of Pentaglobin; Response to empirical antibiotic therapy with modification of the antibiotic (without the addition of antifungal), with the use of Pentaglobin; Response of antibiotic therapy with empirical addition of antifungal with or without the use of Pentaglobin; Mortality at 30 days; Mortality at 90 days

Design of the study Prospective, observational, non-interventional study to determine the incidence of febrile batteries from MDR germs in febrile oncohaematological patients.