Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04270786

Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early de-escalation

Procedure

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

standard

Procedure

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

Primary outcomes

  1. Days of no empirical antibiotics treatment

    Time frame: 28 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiong HU

CONTACT

[email protected]

86-21-64370045

Ling Wang

CONTACT

[email protected]

86-21-64370045 ext. 601878

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2020
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.