Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla157 enrolled

Overview

Clinical trial intended to reduce the antibiotic therapy duration in "in-hospital" patients with haematological diseases who develop fever and low white blood cell count (neutropenia).

The optimal duration of the empirical antimicrobial therapy (AT) in hematological patients with febrile neutropenia (FN) is unknown. The Infectious Diseases Society of America (IDSA) recommends maintaining AT at least until the neutropenia is recovered, because literally "years of experience have proven this approach to be safe and effective". This recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by IDSA. The main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical AT in hematological patients with FN).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

157

Conditions

Febrile Neutropenia

Interventions

Empirical antimicrobial treatment discontinuationDRUG

Empirical antimicrobial treatment discontinuation will occur when the patient is: Afebrile, with resolution of signs, symptoms and test abnormalities secondary to complementary source of infection and with normalization of vital signs for ≥ 72 h.

Standard empirical antimicrobial treatment discontinuationDRUG

The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation. * Informed consent signed. Exclusion Criteria: * Fever with etiologic diagnosis. * Patients with epilepsy. * Pregnant or lactating women. * Patients with HIV infection. * Patients with severe renal failure.

Locations (6)

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Clínic

Barcelona, Spain

Bellvitge University Hospital

Barcelona, Spain

Outcomes

Primary Outcomes

Number of days on which patient is free of antimicrobial treatment

Protocol visits: Screening visit, Randomization visit, at 72h. of apyrexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit).

Time frame: 28 days following the initiation of empiric antibiotic treatment.

Secondary Outcomes

Crude mortality

Number of died patients

Time frame: 28 days following the initiation of empiric antibiotic treatment.

Number of days of fever

Time frame: 28 days following the initiation of empiric antibiotic treatment

Data from ClinicalTrials.gov

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