Personalized antibiotic duration for high-risk febrile neutropenia with Gram-negative bloodstream infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label trial that assigns hospitalized patients with hematologic malignancies and Gram-negative bacteraemia 1:1 to either stop antibiotics once they maintain clinical stability for 72 consecutive hours or to continue standard care with a suggested minimum of 10 days of therapy. Clinical stability is defined by sustained resolution of fever and stable or improving qSOFA score. A parallel microbiological sub-study uses shotgun metagenomic sequencing of stool, rectal swabs, and blood at baseline, end of treatment, and day 28 to compare microbiome recovery and acquisition of antimicrobial-resistance genes. All participants are followed clinically through day 28 to capture safety and antibiotic-free days outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed with a hematologic malignancy that is candidate for treatment with chemotherapy or bone marrow transplantation or chimeric antigen receptor T cell therapy (CAR-T)
* Diagnosis of febrile neutropenia defined according to the guidelines of the Infectious Disease Society of America, IDSA; ref: Freifeld, A.G., et al., Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis, 2011. 52(4): p. e56-93.) as: Fever: single record of oral temperature \>=38.3°C or a temperature \>=38.0°C sustained over a period of one hour; Neutropenia: absolute neutrophil count \< 1000 cells/microL; Expected duration of neutropenia \>= 7 days
* Diagnosis of bacteraemia defined by positive blood cultures (at least 1 vial positive for a non-contaminating microorganism)
* Isolation of Gram-Negative species

Exclusion Criteria:

* Contextual diagnosis of pneumonia
* Contextual diagnosis of intra-abdominal infection, in particular: neutropenic enterocolitis/typhlitis or biliary tract infection
* Persistently positive blood cultures at randomization
* Any condition that endangers the safety of the patient based on the judgment of the treating physician

Where it's running

• Microbiology and Virology - IRCCS Humanitas Research Hospital
  Rozzano, Milan, Italy Recruiting

Study contacts

• Principal investigator: Valeria Cento, MD, PhD — Humanitas University
• Study coordinator: Valeria Cento, MD, PhD
• Email: valeria.cento@hunimed.eu
• Phone: 0282243166

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.