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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Febrile Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extended infusion

Piperacillin-tazobactam, cefepime or meropenem will be administered in half time of the dosing interval

Group Type EXPERIMENTAL

Piperacillin-Tazobactam 4 g-0.5 g

Intervention Type DRUG

Patients with FN who empirical treatment with piperacillin-tazobactam 4g/6h

Cefepime 2000 mg

Intervention Type DRUG

Patients with FN who required empirical treatment with cefepime 2g/8h

Meropenem 1000 mg

Intervention Type DRUG

Patients with FN who required empirical treatment with meropenem 1g/8h

Intermittent infusion

Piperacillin-tazobactam, cefepime or meropenem will be administered in 30 minutes

Group Type ACTIVE_COMPARATOR

Piperacillin-Tazobactam 4 g-0.5 g

Intervention Type DRUG

Patients with FN who empirical treatment with piperacillin-tazobactam 4g/6h

Cefepime 2000 mg

Intervention Type DRUG

Patients with FN who required empirical treatment with cefepime 2g/8h

Meropenem 1000 mg

Intervention Type DRUG

Patients with FN who required empirical treatment with meropenem 1g/8h

Interventions

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Piperacillin-Tazobactam 4 g-0.5 g

Patients with FN who empirical treatment with piperacillin-tazobactam 4g/6h

Intervention Type DRUG

Cefepime 2000 mg

Patients with FN who required empirical treatment with cefepime 2g/8h

Intervention Type DRUG

Meropenem 1000 mg

Patients with FN who required empirical treatment with meropenem 1g/8h

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adult patients (age ≥18 years) of both sexes.
2. Patients admitted in Hematological wards.
3. With any of the following diagnoses:

1. Acute leukemia receiving chemotherapy.
2. Autologous or allogeneic hematopoietic stem cell transplant recipients.
4. With an episode of febrile neutropenia: ≥ 38.0ºC and \<500 neutrophils/mm3 or \<1000 with a predicted decrease within 24-48 hours.
5. Patient requiring treatment with a beta-lactam antibiotic: cefepime, piperacillin /tazobactam or meropenem, in monotherapy or in combination with another antibiotic.
6. Written informed consent has been obtained from the patient or their legal representative grants.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No