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Early Neutropenic Fever De-escalation of Antibiotics Study

ConditionsHematologic MalignancyFebrile NeutropeniaAntibiotic Stewardship
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
60 days
2

Antibiotic utilization

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

Time frame
60 days

Secondary outcomes

1

Mortality post F&N

To compare the rates of mortality within 60 days after first neutropenic fever in each arm.

Time frame
60 days
2

Drug resistance

To compare the rates of acquisition of multidrug resistant gram-negative bacilli (resistant to 3 or more antibiotic classes) and vancomycin resistant enterococci within 60 days after first neutropenic fever in each arm.

Time frame
60 days
3

Clostridium difficile infection

To compare the rates of Clostridium difficile infection (CDI) within 60 days after first neutropenic fever infection in each arm.

Time frame
60 days
4

Candidiasis

To compare the rates of candidemia and invasive candidiasis within 60 days after first neutropenic fever in each arm.

Time frame
60 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Dana-Farber Cancer Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: