About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Early de-escalation
Procedure/SurgeryIn de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.
Standard
Procedure/SurgeryIn the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.
Treatment groups
Trial outcomes
Primary outcomes
Days of no empirical antibiotics treatment
days from start of empirical antibiotics to end of study minus days with empirical antibiotics
Sponsors and contacts
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