Actively Recruiting
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-02-18
200
Participants Needed
1
Research Sites
338 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Undergoing hematopoietic stem cell transplantation
- Neutropenic fever defined as temperature ≥38.5°C once or ≥38.0°C twice daily with absolute neutrophil count <0.5x10^9/L or predicted to be <0.5x10^9/L within 24 to 48 hours
- Afebrile (temperature <37.5°C) for at least 72 hours
- Provided informed consent
You will not qualify if you...
- Neutropenic fever with documented bloodstream infection, skin and soft tissue infection, pneumonia, or catheter-associated infection
- Presence of septic shock
- Allergy or contraindication to levofloxacin
AI-Screening
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Trial Site Locations
Total: 1 location
1
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
L
Ling Wang
CONTACT
J
Jiong HU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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