Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

Safety Issues Clinical Trial

Official title:

Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270786
• Other study ID #: 2019-BMT-Antibio
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Ling Wang
• Phone: 86-21-64370045
• Email: cclingjar[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Febrile Neutropenia
• Safety Issues

Intervention

Procedure:
• Early de-escalation
In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.
• Standard
In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.

Locations

Country	Name	City	State
China	Blood & Marrow Transplantation Center, RuiJin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of no empirical antibiotics treatment	days from start of empirical antibiotics to end of study minus days with empirical antibiotics	28 days