Early Neutropenic Fever De-escalation of Antibiotics Study

NCT06278896 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 23-684-END
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hematologic Malignancy; Febrile Neutropenia; Antibiotic Stewardship

Keywords

Febrile Neutropenia

Outcome Measures

Primary Outcomes (2)

• Mortality, transfer to the ICU, septic shock, culture-confirmed bacteremia

  To compare number of patients with a 60-day composite of mortality, transfer to the ICU, septic shock, culture-confirmed bacteremia in each arm.

  60 days

• Antibiotic utilization

  To compare the days of antibiotic spectrum coverage (DASC), in each arm between randomization and count recovery.

  60 days

Secondary Outcomes (11)

• Mortality post F&N

  60 days

• Drug resistance

  60 days

• Clostridium difficile infection

  60 days

• Candidiasis

  60 days

• Adverse Events

  60 days

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Drug: Cessation of antibiotics

Control Arm

NO INTERVENTION

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.

Interventions

Cessation of antibiotics DRUG

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.

Also known as: Stop antibiotics

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• High-risk neutropenia defined as expected duration of absolute neutrophil count less than 500 cells/µL for seven or more days.
• Admitted as an inpatient at Mass General Brigham or Dana Farber Cancer Institute (DFCI).
• 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.
• Has been afebrile for 48 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Dana-Farber Cancer Institute: collaborator

MeSH Terms

Conditions

Hematologic Neoplasms; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Study Officials

• Lindsey R Baden, MD

  Brigham and Women's Hospital, Dana Farber Cancer Institute, Harvard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey R Baden, MD

CONTACT

617-525-8418; lbaden@bwh.harvard.edu

Alisse D Hannaford, MD

CONTACT

617-525-8418; ahannaford@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share