Actively Recruiting
Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-02-18
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of stopping empirical antibiotics early in patients with neutropenic fever who are undergoing hematopoietic stem cell transplantation (HSCT). This trial compares early de-escalation of antibiotics with standard treatment to see if patients can safely reduce antibiotic use. All participants have neutropenic fever and have been treated with empirical antibiotics including imipenem, and vancomycin if fever persists. Participants start with empirical antibiotics when fever develops during neutropenia. After being fever-free for 72 hours, patients are randomly assigned to one of two groups. In the early de-escalation group, empirical antibiotics are stopped and levofloxacin prophylaxis is resumed. The control group continues empirical antibiotics until neutropenia resolves or for at least 7 days. Levofloxacin is given regularly as prophylaxis during the transplantation process. During the study, researchers monitor the duration without empirical antibiotics over 28 days. Patients will be assessed for safety and feasibility of stopping antibiotics early. The study tracks fever status, blood counts, and infections. Participation lasts through the neutropenic fever episode and includes follow-up to measure outcomes. The trial is randomized with no masking and aims to gather data on antibiotic use in this setting.
CONDITIONS
Brief Title
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients undergoing hematopoietic stem cell transplantation
- Neutropenic fever defined as temperature ≥38.5°C once or ≥38°C twice daily with an absolute neutrophil count below 0.5 x 10^9/L or predicted to be below this level within 24 to 48 hours
- Afebrile (temperature below 37.5°C) for at least 72 hours
- Informed consent given
You will not qualify if you...
- Patients with neutropenic fever and documented bloodstream infection, skin and soft tissue infection, pneumonia, or catheter-associated infection
- Patients with septic shock
- Allergy or contraindication to levofloxacin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Until recovery of neutropenia or at least 7 days after afebrile
Participants receive empirical antibiotics treatment when neutropenic fever develops after hematopoietic stem cell transplantation. Those who become afebrile for at least 72 hours are randomized to either early de-escalation of antibiotics or continuation of standard empirical antibiotics until recovery of neutropenia or at least 7 days.
Visits as needed during antibiotic treatment
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
J
Jiong HU
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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