Efficacy of Extended Infusion of β-lactam Antibiotics for the Treatment of Febrile Neutropenia in Hematologic Patients (BEATLE)

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    150
  • sponsor
    Hospital Universitari de Bellvitge
Updated on 24 February 2022
antibiotic therapy
antibiotics
stem cell transplantation
leukemia
meropenem
neutrophil count
piperacillin-tazobactam
cefepime

Summary

This study evaluates the administration of beta-lactam antibiotics in extended infusion in hematological patients with febrile neutropenia after 5 days of treatment. The beta-lactam antibiotics analyzed are the following: piperacillin-tazobactam, cefepime and meropenem. Half of patients will receive the antibiotic in intermittent infusion, while the other half will receive it in extended infusion.

Description

Febrile neutropenia (FN) is a very frequent complication in patients with hematological malignancies. It is associated with an important morbidity and mortality. Nowadays the use of betalactam antibiotics (BLA) in extended or continuous infusion (EI, CI) instead of intermittent infusion (II), has demonstrated a therapeutic success and lower mortality rate in critically ill intensive care patients. Neutropenic patients are a particular population since FN is assoicated with pathophysiological variations that compromise pharmacokinetic parameters of BLA, and may therefore, diminish their clinical efficacy. Information regarding the usefulness of BLA in EI in neutropenic hematologic patients is scarce.

The objective of this randomized clinical trial is to demonstrate the clinical superiority of the administration of BLA in EI compared to II in patients with FN.

Details
Condition Febrile Neutropenia
Treatment Piperacillin-Tazobactam 4 g-0.5 g, Cefepime 2000 mg, Meropenem 1000 mg
Clinical Study IdentifierNCT04233996
SponsorHospital Universitari de Bellvitge
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients (age 18 years) of both sexes
Patients admitted in Hematological wards
With any of the following diagnoses
Acute leukemia receiving chemotherapy
Autologous or allogeneic hematopoietic stem cell transplant recipients
With an episode of febrile neutropenia: 38.0C and <500 neutrophils/mm3 or <1000 with a predicted decrease within 24-48 hours
Patient requiring treatment with a beta-lactam antibiotic: cefepime, piperacillin /tazobactam or meropenem, in monotherapy or in combination with another antibiotic
Written informed consent has been obtained from the patient or their legal representative grants

Exclusion Criteria

Allergy to study drugs
Patient receiving systemic antibiotic treatment (except for prophylaxis) at the time of onset of febrile neutropenia
Absence of fever
Patients with epilepsy
Severe renal impairment (defined as creatinine clearance <30 mL / min)
Previously enrolled patients in whom the time between the inclusion and the current episode is less than 5 weeks
Previously enrolled patients without current resolution of the first episode
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