Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation

Conditions
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Safety Issues

Intervention / Treatment
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* Procedure: Early de-escalation
* Procedure: Standard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early de-escalation<br>In the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours. | Procedure: Early de-escalation<br>* In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.<br>|
| Other: Standard<br>In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice. | Procedure: Standard<br>* In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of no empirical antibiotics treatment | days from start of empirical antibiotics to end of study minus days with empirical antibiotics | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutropenic fever, empiric, antibiotics