Ireland
--:--IST
Recruiting Not applicable

Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

NCT04270786 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2020-01-01
Last updated
2025-02-18

Condition(s) studied

Safety Issues

Investigational drug(s) / intervention(s)

Early de-escalationStandard

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Days of no empirical antibiotics treatment — 28 days
    days from start of empirical antibiotics to end of study minus days with empirical antibiotics

Trial sites (1)

FacilityCityRegionStatus
Blood & Marrow Transplantation Center, RuiJin Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04270786 on ClinicalTrials.gov ↗ ← All trials in China