To hear about similar clinical trials, please enter your email below
Trial Title:
Early Neutropenic Fever De-escalation of Antibiotics Study
NCT ID:
NCT06278896
Condition:
Hematologic Malignancy
Febrile Neutropenia
Antibiotic Stewardship
Conditions: Official terms:
Hematologic Neoplasms
Neutropenia
Febrile Neutropenia
Anti-Bacterial Agents
Antibiotics, Antitubercular
Conditions: Keywords:
Febrile Neutropenia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cessation of antibiotics
Description:
Stop antibiotic therapy after episode of fever if afebrile for 48 hours, no clinically
documented source of bacterial infection, and no hemodynamic or respiratory
decompensation.
Arm group label:
Intervention Arm
Other name:
Stop antibiotics
Summary:
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.
Detailed description:
Background:
The Infectious Disease Society of America (IDSA) guidelines for febrile neutropenia
conflict with several other international guidelines on duration of antibiotic therapy in
patients with febrile neutropenia without a documented infectious source. The IDSA
recommends continuing antibiotic therapy until clear signs of marrow recovery, while
other guidelines, including the European guidelines, allow for earlier discontinuation if
no source of bacterial infection is identified. Benefits of earlier discontinuation of
antibiotics include mitigating the risk of induction and amplification of antibiotic
resistance, decreased disruption of the microbiome, as well as minimizing potential side
effects and complications associated with long-term antibiotic use. To date the only
randomized clinical trial in adults evaluating an abridged course of antibiotic therapy
in high-risk patients with febrile neutropenia (defined as neutropenia for at least 7
days) was a superiority study that demonstrated fewer days of antibiotic use in the
control arm. Safety data were a secondary outcome. Further research is needed to assess
the safety and clinical outcomes of targeted antibiotic therapy for patients with febrile
neutropenia.
Study Design:
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.
Treatment Regimen:
Intervention Arm (Arm A): Stop antibiotic therapy after episode of fever if afebrile for
48 hours, no clinically documented source of bacterial infection, and no hemodynamic or
respiratory decompensation.
Control Arm (Arm B): Continue antibiotic therapy per IDSA guidelines until count recovery
and/or standard of care as deemed by inpatient providers.
Study Participants:
The study population will comprise adults who have hematologic high-risk neutropenia
(likely > 7 days).
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2024
Completion date:
March 1, 2028
Lead sponsor:
Agency:
Brigham and Women's Hospital
Agency class:
Other
Collaborator:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Brigham and Women's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06278896
