Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2026-06-30

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.

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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.

Conditions

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Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early de-escalation

In the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours.

Group Type EXPERIMENTAL

Early de-escalation

Intervention Type PROCEDURE

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

Standard

In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice.

Group Type OTHER

Standard

Intervention Type PROCEDURE

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

Interventions

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Early de-escalation

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

Intervention Type PROCEDURE

Standard

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No