Early Neutropenic Fever De-escalation of Antibiotics Study

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Feb 23, 2024

Keywords

ClinConnect Summary

The Early Neutropenic Fever De-escalation of Antibiotics Study is a clinical trial that aims to investigate whether it is safe and effective to reduce antibiotic treatment for patients with neutropenic fever— a condition where patients have a fever but no bacterial infection has been found. This study is specifically for adults over 18 years old who have certain blood disorders, like leukemia or multiple myeloma, and who are likely to have low white blood cell counts for more than a week. Participants must be hospitalized and have had a fever but have been fever-free for at least 48 hours.

If you qualify for this trial, you'll be part of a group that helps researchers understand if reducing antibiotics can still keep you safe and healthy. The study is not yet recruiting participants, but it will involve close monitoring and care during your hospital stay. It's important to note that you cannot have a suspected bacterial infection or have received certain antibiotics shortly before your fever to be eligible. Your participation could contribute to better treatment options for future patients in similar situations.

Gender

ALL

Eligibility criteria

• 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.