This phase III trial compares the effects of early discontinuation of antibiotic therapy versus standard of care on clinical outcomes in patients with hematologic conditions and neutropenic fever in which no bacterial infection has been identified. When individuals have a compromised immune system with a low white blood cell count, specifically with a low neutrophil count, they are at higher risk of developing infections. Currently, when individuals with a low neutrophil count develop a fever, they are treated with long courses of antibiotics in case of a bacterial infection, even if no bacterial infection is found. This trial evaluates whether a shortened period of antibiotic treatment after the development of a fever where no bacterial infection is identified is safe and still provides the same benefit as having the standard duration of antibiotics.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06278896.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Lindsey Robert Baden
Dana-Farber Cancer InstituteStatus: Active
Contact: Lindsey Robert Baden
PRIMARY OBJECTIVES:
I. To compare 60-day outcomes of a composite endpoint including: mortality, transfer to the intensive care unit (ICU), septic shock, culture-confirmed bacteremia.
II. To compare the days of antibiotic spectrum coverage (DASC), in each arm between randomization and count recovery.
SECONDARY OBJECTIVES:
I. To compare the rates of mortality within 60 days after first neutropenic fever in each arm.
II. To compare the rates of acquisition of multidrug resistant (MDR) gram-negative bacilli (GNB) (resistant to 3 or more antibiotic classes) and vancomycin-resistant enterococci (VRE) within 60 days after first neutropenic fever in each arm.
III. To compare the rates of Clostridium difficile (CDI) within 60 days after first neutropenic fever infection in each arm.
IV. To compare the rates of candidemia and invasive candidiasis within 60 days after first neutropenic fever in each arm.
V. To compare the rates of grade 3, 4, and 5 adverse events in each arm within 60 days after first neutropenic fever.
VI. To compare the rates of allergic reactions or side effects attributed to antibiotics that required antibiotic cessation or change within 60 days after first neutropenic fever.
VII. To compare the rates of bacteremia within 60 days after randomization.
VIII. To compare the rates of neutropenia at antibiotic stop date.
IX. To compare the length of hospital stay in each arm.
X. To compare the rates of non-elective hospital readmission within 60 days in each arm.
XI. To compare the rates of new fever after index fever in each arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo early discontinuation of antibiotic therapy once afebrile for at least 48 hours, no clinically documented source of bacterial infection, and no hemodynamic or respiratory decompensation.
ARM B: Patients continue antibiotic therapy until count recovery and/or for the standard duration, per standard of care.
Patients are followed up for 60 days after enrollment on study.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorLindsey Robert Baden
