Early Antibiotic Deescalation and Discontinuation in Patients with Febrile Neutropenia after Cellular Therapy: A Single-Center Prospective Unblinded Randomized Trial

Ron Ram*, Odelia Amit, Amos Adler, Yael Bar-On, Ofrat Beyar-Katz, Irit Avivi, David Shasha, Ronen Ben-Ami

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

The optimal duration of empiric antimicrobial therapy of febrile neutropenia in patients after cellular therapy is unclear. Early deescalation has been suggested by some authorities; however, data are lacking for cellular therapy recipients. We performed a randomized controlled study of cellular therapy recipients with febrile neutropenia to evaluate the safety and noninferiority of an early deescalation and discontinuation antibiotic strategy (EDD arm) versus standard broad-spectrum antibiotic treatment until recovery of neutropenia (standard duration arm). The primary outcome was the fraction of antibiotic-free neutropenia days. We randomized 110 patients to the standard duration arm (n = 51) or EDD arm (n = 59). The fraction of antibiotic-free neutropenia days was higher in the EDD arm compared to the standard duration arm (median,.8 [interquartile range (IQR),.62 to.86] versus.51 [IQR,.17 to.86]; P =.016). This was true for the per-protocol, allogeneic hematopoietic cell transplantation (HCT), autologous HCT, and anti-CD19 chimeric antigen receptor T cell therapy subgroups. Treatment success rate, subsequent fever, death within 30 days, and other common cellular therapy-related toxicities were all similar between the 2 study arms. An EDD antibiotic strategy in patients after cellular therapy was safe and associated with a substantial reduction in broad-spectrum antibiotic utilization without compromising cellular therapy outcomes.

Original languageEnglish
Pages (from-to)708.e1-708.e8
JournalTransplantation and Cellular Therapy
Volume29
Issue number11
DOIs
StatePublished - Nov 2023

Funding

FundersFunder number
Pfizer
Merck

    Keywords

    • Antibiotic
    • CAR-T
    • Hematopoietic cell transplantation
    • Infections

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