Clinical trial · Interventional
Early Neutropenic Fever De-escalation of Antibiotics Study
Early Neutropenic Fever De-escalation (END) of Antibiotics Study
NCT06278896CI-TRIAL-00074384ENDnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic Stewardship | — | UNRESOLVED | — |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cessation of antibiotics | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- Participants will stop empiric antibiotic therapy after their episode of fever if afebrile for 48 hours, no clinically documented source of bacterial infection, and no hemodynamic or respiratory decompensation.
- interventionNames
- Drug: Cessation of antibiotics
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Participants will continue antibiotic therapy until count recovery and/or standard of care as deemed by inpatient providers, which is the current guidelines recommended by the IDSA.
Primary outcomes (2)
- measure
- Mortality, transfer to the ICU, septic shock, culture-confirmed bacteremia
- timeFrame
- 60 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.