Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
Primary Purpose
Safety Issues
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early de-escalation
Standard
Sponsored by
About this trial
This is an interventional treatment trial for Safety Issues focused on measuring neutropenic fever, empiric, antibiotics
Eligibility Criteria
Inclusion Criteria:
- Age ≥18,patients undergo hematopoietic stem cells
- Patients with neutropenic fever: T≥38.5°C once or T≥38°C twice a day with ANC <0.5x109/L or predicted to be <0.5x109/L in 24 ~48 hours;
- Patients achieved afebrile (T<37.5°C)for at least 72 hours;
- Inform consent given
Exclusion Criteria:
- Patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection.
- Patients with septic shock
- Levofloaxin allergy or contra-indication
Sites / Locations
- Blood & Marrow Transplantation Center, RuiJin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Early de-escalation
Standard
Arm Description
In the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours.
In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice.
Outcomes
Primary Outcome Measures
Days of no empirical antibiotics treatment
days from start of empirical antibiotics to end of study minus days with empirical antibiotics
Secondary Outcome Measures
Full Information
NCT ID
NCT04270786
First Posted
February 13, 2020
Last Updated
November 23, 2021
Sponsor
Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04270786
Brief Title
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
Official Title
Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). In case of afebrile for 72 hours with empirical antibiotics treatment, patients will be randomized into 2 groups. In the early de-escalation group, antibiotics treatment will be stopped and prophylaxis with levofloxacin will be resumed. In the control group, the empirical treatment will continue until recovery of neutropenia or at least for 7 days.
Detailed Description
This is a randomized study to evaluate the safety and feasibility of early de-escalation treatment of empyrical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). All patients undergoing HSCT will receive levofloxacin as regular prophylaxis. After patients develop neutropenia fever, the empirical antibiotics protocol will be impenem. In case of persistent for 48 hours, vancomycin will be added. If afebrile is achieved for 72 hours, all patients will randomized into early de-escalating group or control group. In de-escalating group, the empirical antibiotics treatment will be stopped and then levofloxacin prophylaxis will be resumed. In the control group, the empirical antibiotics treatment will be continue until recovery of neutropenia or at least 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues
Keywords
neutropenic fever, empiric, antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early de-escalation
Arm Type
Experimental
Arm Description
In the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours.
Arm Title
Standard
Arm Type
Other
Arm Description
In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice.
Intervention Type
Procedure
Intervention Name(s)
Early de-escalation
Intervention Description
In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.
Intervention Type
Procedure
Intervention Name(s)
Standard
Intervention Description
In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.
Primary Outcome Measure Information:
Title
Days of no empirical antibiotics treatment
Description
days from start of empirical antibiotics to end of study minus days with empirical antibiotics
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18,patients undergo hematopoietic stem cells
Patients with neutropenic fever: T≥38.5°C once or T≥38°C twice a day with ANC <0.5x109/L or predicted to be <0.5x109/L in 24 ~48 hours;
Patients achieved afebrile (T<37.5°C)for at least 72 hours;
Inform consent given
Exclusion Criteria:
Patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection.
Patients with septic shock
Levofloaxin allergy or contra-indication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Wang
Phone
86-21-64370045
Ext
601878
Email
cclingjar@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiong HU
Phone
86-21-64370045
Email
hj10709@rjh.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiong hu
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blood & Marrow Transplantation Center, RuiJin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiong HU, M.D.,
Phone
86-21-64370045
Email
hujiong@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Ling Wang, M.D.,
Phone
86-21-64370045
Email
cclingjar@163.com
12. IPD Sharing Statement
Learn more about this trial
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
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