Early Neutropenic Fever De-escalation of Antibiotics Study
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Participant or healthcare proxy with the ability to understand and willingness to sign an informed consent.
Adults >18 years old.
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.
Received or planned to receive cytotoxic chemotherapy. No restrictions on prior therapy regarding dose or agent.
Disqualifiers
Microbiologically or clinically suspected bacterial infection after index fever.
Exposure to treatment antibacterial therapy 72 hours before first fever occurrence other than antibiotics deemed as prophylaxis.
Trial design
Treatments tested in this trial
- Cessation of antibiotics
Treatment groups
260 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Dana-Farber Cancer Institute
Collaborator
Source ClinicalTrials.gov