Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

NCT04270786 | Recruiting

• 1 other identifier: 2019-BMT-Antibio
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety Issues

Keywords

neutropenic fever, empiric, antibiotics

Outcome Measures

Primary Outcomes (1)

• Days of no empirical antibiotics treatment

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

  28 days

Study Arms (2)

Early de-escalation

EXPERIMENTAL

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

Procedure: Early de-escalation

Standard

OTHER

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

Procedure: Standard

Interventions

Early de-escalation PROCEDURE

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

Early de-escalation

Standard PROCEDURE

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

Standard

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Jiong hu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Wang

CONTACT

86-21-64370045; cclingjar@163.com

Jiong HU

CONTACT

86-21-64370045; hj10709@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Blood and Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: January 1, 2020
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

CN (1)