Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

  • STATUS
    Recruiting
  • End date
    Dec 30, 2021
  • participants needed
    200
  • sponsor
    Shanghai Jiao Tong University School of Medicine
Updated on 23 January 2021
antibiotics
fever

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.

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.

Details
Condition Safety Issues
Treatment standard, Early de-escalation
Clinical Study IdentifierNCT04270786
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18patients undergo hematopoietic stem cells
Patients with neutropenic fever: T38.5C once or T38C twice a day with ANC <0.5x109/L or predicted to be <0.5x109/L in 24 ~48 hours
Patients achieved afebrile T<37.5Cfor 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
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