Efficacy of Extended Infusion of β-lactam Antibiotics for the Treatment of Febrile Neutropenia in Hematologic Patients
BEATLE
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2019
CompletedFirst Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 12, 2021
February 1, 2021
2.6 years
September 4, 2019
February 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical efficacy of extended infusion: Number of patients with defervescence
Number of patients with defervescence (\<37.5 ºC, for 24 hours) without modifying the antibiotic treatment
5 days
Secondary Outcomes (14)
Pharmacokinetic target
5 days
Inflammatory biomarker
5 days
Overall mortality at 30 days
30 days
Bacteraemia clearance
30 days
Adverse events
30 days
- +9 more secondary outcomes
Study Arms (2)
Extended infusion
EXPERIMENTALPiperacillin-tazobactam, cefepime or meropenem will be administered in half time of the dosing interval
Intermittent infusion
ACTIVE COMPARATORPiperacillin-tazobactam, cefepime or meropenem will be administered in 30 minutes
Interventions
Patients with FN who empirical treatment with piperacillin-tazobactam 4g/6h
Patients with FN who required empirical treatment with cefepime 2g/8h
Patients with FN who required empirical treatment with meropenem 1g/8h
Eligibility Criteria
You may qualify if:
- 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: ≥ 38.0ºC 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.
You may not qualify if:
- 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 without current resolution of the first episode.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitari de Bellvitgelead
- Institut d'Investigació Biomèdica de Bellvitgecollaborator
- Instituto de Salud Carlos IIIcollaborator
Study Sites (1)
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Related Publications (1)
Laporte-Amargos J, Gudiol C, Arnan M, Puerta-Alcalde P, Carmona-Torre F, Huguet M, Albasanz-Puig A, Parody R, Garcia-Vidal C, Del Pozo JL, Batlle M, Tebe C, Rigo-Bonnin R, Munoz C, Padulles A, Tubau F, Videla S, Sureda A, Carratala J. Efficacy of extended infusion of beta-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE). Trials. 2020 May 18;21(1):412. doi: 10.1186/s13063-020-04323-0.
PMID: 32423462DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlota Gudiol, PhD
Hospital Universitari de Bellvitge
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2019
First Posted
January 21, 2020
Study Start
June 5, 2019
Primary Completion
December 30, 2021
Study Completion
December 31, 2022
Last Updated
February 12, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share