Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278896
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-01-03
Brief Title:
Early Neutropenic Fever De-escalation of Antibiotics Study
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Early Neutropenic Fever De-escalation END of Antibiotics Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
END
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
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None