Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
Shanghai Jiao Tong University School of Medicine
200 participants
Jan 1, 2020
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria3
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.
In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04270786