Early Neutropenic Fever De-escalation (END) of Antibiotics Study

23-684-END

This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed with neutropenic fever, in which no bacterial infection has been identified.

2024-03-01

2026-03-01

2028-03-01

Not yet recruiting

Early phase I

260

Inclusion Criteria: 1. Participant or healthcare proxy with the ability to understand and willingness to sign an informed consent. 2. Adults \>18 years old. 3. Likely to have neutropenia \> 7 days including such conditions as: acute leukemia; lymphoproliferative disease; multiple myeloma; myelodysplastic syndrome; bone marrow aplasia and autologous or allogeneic hematopoietic stem cell transplantation. Neutropenia defined as absolute neutrophil count \<500. 4. Received or planned to receive cytotoxic chemotherapy. No restrictions on prior therapy regarding dose or agent. 5. High-risk neutropenia defined as expected duration of absolute neutrophil count less than 500 cells/µL for seven or more days. 6. Admitted as an inpatient at Mass General Brigham or Dana Farber Cancer Institute (DFCI). 7. Initial fever (defined as a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period) during hospital admission or as reason for admission. 8. Has been afebrile for 48 hours. Exclusion Criteria: 1. Microbiologically or clinically suspected bacterial infection after index fever. 2. Exposure to treatment antibacterial therapy 72 hours before first fever occurrence other than antibiotics deemed as prophylaxis.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 260, 'type': 'ESTIMATED'}}

2024-02-26