Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients

Summary

The goal of this clinical trial is to learn if a personalized duration of antibiotic therapy, based on clinical stability, is as effective as a standard duration of at least 10 days in hospitalized patients with hematologic malignancies (such as leukemia or lymphoma) who develop febrile neutropenia and Gram-negative bacteraemia.

The main questions it aims to answer are:

* Can a personalized antibiotic duration increase the number of days free from anti-Gram-negative therapy within 28 days without compromising patient safety?
* How does the duration of antibiotic therapy (short vs. prolonged) affect the rate and modality of gut microbiota reconstitution?

Researchers will compare:

* Group A (Personalized Duration): Antibiotics are stopped after the patient maintains clinical stability (no fever and stable vital signs) for 72 consecutive hours.
* Group B (Standard of Care): Antibiotics are continued for a standard duration, typically at least 10 days, based on current clinical surveys and physician decision.

Participants will:

* Be randomized to receive either the personalized or the standard duration of antibiotic therapy once a Gram-negative infection is confirmed in the blood.
* Be monitored for 28 days to assess for new fever episodes, recurrence of infection, and overall survival.
* If participating in the microbiological sub-study, provide biological samples (blood, feces, and rectal swabs) at specific time points (at the onset of fever, at the end of treatment, and at day 28).
* Undergo specialized laboratory testing (Whole Metagenomic Sequencing) on the collected samples to evaluate the evolution of their intestinal and blood microbiota and the presence of antibiotic-resistant genes.

Conditions

• Bloodstream Infection
• Gram Negative Infections
• Bacteraemia Caused by Gram-Negative Bacteria
• Febrile Neutropenia (FN)

Interventions

OTHER

Clinical Stability-Driven Antibiotic Discontinuation Strategy

A therapeutic strategy where the duration of antibiotic treatment for Gram-negative bacteraemia is determined by the achievement of clinical stability (defined as apyrexia for 48h and stable/improved qSOFA score) maintained for 72 consecutive hours

OTHER

Standard of Care Antibiotic Duration

This intervention follows the standard clinical practice for treating Gram-negative bacteraemia in hematological patients. The duration of therapy is not fixed by a stability-driven rule but is based on the treating physician's decision, with a suggested minimum of 10 days.

Sponsors & Collaborators

• Ministry of education, university and research, Italy

  collaborator UNKNOWN

• Valeria Cento

  lead OTHER

Principal Investigators

• Valeria Cento, MD, PhD · Humanitas University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-25

Primary Completion

2028-02-28

Completion

2028-11-30

Countries

• Italy

Study Locations