Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

ConditionSafety Issues
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Jiao Tong University School of Medicine

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

Qualifiers

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

Treatments tested in this trial

  • Early de-escalation
  • Standard

Treatment groups

200 Participants
are divided into 2 treatment groups