Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

Shanghai Jiao Tong University School of Medicine

Status: Enrolling

Conditions: Safety Issues

Treatments: Procedure: Early de-escalation; Procedure: Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT04270786

2019-BMT-Antibio

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Early de-escalation

Experimental group

Description:

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

Treatment:

Procedure: Early de-escalation

Standard

Other group

Description:

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

Treatment:

Procedure: Standard