Early Antibiotic Discontinuation in FUO

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be responsible for side-effects and selection of resistance. This study demonstrates the safety of an early discontinuation of empirical treatments, in carefully selected patients presenting with fever of unknown origin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Short Antibiotic Treatment in High Risk Febrile Neutropenia

NCT05786495

Febrile Neutropenia

RECRUITING NA

Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia

NCT04910698

Bloodstream Infection Acute Myeloid Leukemia Febrile Neutropenia

COMPLETED

AMS Intervention for Early Adaptation of Empirical Antibiotic Therapy in High-risk Neutropenic Patients

NCT05793073

Neutropenia

COMPLETED

Short-term Antibiotic Treatment for Unexplained Fever in Solid Cancer Patients With Febrile Neutropenia

NCT01450241

Febrile Neutropenia

WITHDRAWN NA

Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies/Receiving Cellular Therapies and Fever

NCT07051525

Leukemia CART Therapy Transplantation, Stem Cell +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Infections are responsible for significant morbidity and mortality in haematological patients, in particular during chemotherapy-induced neutropenia. Guidelines recommend immediate initiation of antibiotic therapy, whose optimal duration is unclear. The primary objective of this study is to evaluate early discontinuation of antibiotic treatment for Fever of Unknown Origin (FUO) in afebrile or febrile neutropenic patients. The secondary objective is to describe the epidemiology of febrile neutropenia (FN) in investigator centre.

Every episode of FN was prospectively identified. In the first phase of the study, empirical antibiotic therapy of FUO patients was stopped after 48 hours of apyrexia, in accordance with ECIL-4 (European Conference on Infections in Leukaemia) recommendations. In the second phase of the study, antibiotics were stopped on day 5 for all FUO patients, regardless of their temperature or their leukocyte count.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Febrile Neutropenia Hematological Malignancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ECIL-4 guidelines group

For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia:

\- From 1st February 2014 to 30th November 2014, antibiotics were stopped when patients had been afebrile for more than 48 hours, as recommended by the ECIL-4 guidelines

ECIL-4 guidelines group

Intervention Type OTHER

Antibiotics were stopped when patients had been afebrile for more than 48 hours

short-course antibiotic therapy

For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia:

\- From 1st December 2014 to 30th September 2015, antibiotics were stopped on day 5 in febrile or afebrile patients (short-course antibiotic therapy).

ECIL-4 guidelines group

Intervention Type OTHER

Antibiotics were stopped when patients had been afebrile for more than 48 hours

Short-course antibiotic therapy

Intervention Type OTHER

Antibiotics were stopped on day 5 in febrile or afebrile patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ECIL-4 guidelines group

Antibiotics were stopped when patients had been afebrile for more than 48 hours

Intervention Type OTHER

Short-course antibiotic therapy

Antibiotics were stopped on day 5 in febrile or afebrile patients

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age ≥ 18 years;
* presence of a malignant haematological disease combined with chemotherapy-induced neutropenia (polymorphonuclear neutrophil (PMN) count ≤ 500/mm3)
* fever defined by tympanic temperature of ≥38°C for ≥1 hour or a single temperature of ≥38.3°C