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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Blood & Marrow Transplantation Center, RuiJin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Ling Wang
cclingjar@163.com
86-21-64370045
Backup
Jiong HU
hj10709@rjh.com.cn
86-21-64370045
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 200
Treatments
Experimental: 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.
Other: Standard
In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov

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