Febrile Neutropenia Clinical Trial
Official title:
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With Fever of Unknown Origin: a Randomized Multicenter Non-inferiority Trial.
A multicenter open-label non-inferiority randomized clinical trial comparing the safety (non-inferiority) of short antibiotic treatment (72 hours) with an anti-pseudomonal carbapenem with regard to treatment failure in comparison with extended treatment (at least 9 days) of high-risk febrile neutropenia in hematology patients receiving standard antimicrobial prophylaxis.
Episodes of fever are very common in patients undergoing intensive chemotherapy treatment for
malignant hematological disease. More than 80% of patients experience one or more episodes of
fever after their first cycle of chemotherapy. Only 20-30% of these patients have a
clinically documented focus and mostly include infections of skin, intestinal tract and lung,
while at most 10-25% of these patients have microbiologically proven bacteremia during these
episodes. Patients with malignant hematological diseases and intensive chemotherapy induced
neutropenia are extremely prone to overwhelming bacterial infections. Therefore, empirical
antibiotic treatment is initiated at the first occurrence of fever, even if no apparent cause
for the fever is evident. Most protocols advice treatment with very broad-spectrum
antibiotics, mostly anti-pseudomonal carbapenems or fourth generation anti-pseudomonal
cephalosporins.
Prolonged continuation of treatment may induce bacterial resistance. In view of the possible
emergence of bacterial resistance due to prolonged antibiotic administration, continuation
until recovery of neutropenia is suboptimal because it is costly because of longer hospital
admissions, higher antibiotics costs and more possible adverse reactions.
Recent observational data (Slobbe et al) has showed that in adult hematological patients with
febrile neutropenia, discontinuation of empiric antibacterial therapy after three days can be
safe if no infectious etiology can be found, even in cases with persistent fever. However no
RCT has hitherto been performed to support this observational data.
This study compares the safety (non-inferiority) of short treatment (72 hours) versus
extended treatment (at least 9 days) with an anti-pseudomonal carbapenem for hematology
patients with unexplained high risk febrile neutropenia. We hypothesize that a more
restrictive use of broad-spectrum antibiotic use of three days in unexplained fever in
neutropenic hematology patients is non-inferior to the present extended use during at least 9
days which would lead to a more restrictive use of antibiotics and less multiresistant
strains of bacteria, costs and hospitalization length in the future.
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