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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Early de-escalation

    Procedure/Surgery

    In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.

  • Standard

    Procedure/Surgery

    In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Early de-escalationExperimental treatment 1 intervention
Group B: StandardOther 1 intervention

Trial outcomes

Primary outcomes

1

Days of no empirical antibiotics treatment

days from start of empirical antibiotics to end of study minus days with empirical antibiotics

Time frame
28 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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