Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
Location contact
Jiong HU, M.D.,
CONTACT
Ling Wang, M.D.,
CONTACT
NCT Number: NCT04270786
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
Jiong HU, M.D.,
CONTACT
Ling Wang, M.D.,
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 28 days
days from start of empirical antibiotics to end of study minus days with empirical antibiotics
Contact information is provided by the study sponsor or research team.
Shanghai Jiao Tong University School of Medicine
Other
Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
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.
NCT06485141
Firearm Injury, Safety Issues
Aurora, Colorado, United States
View Trial DetailsNCT07058779
Safety Issues
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05164263
Diabetes Mellitus, Diabetes Mellitus, Type 2
Kabul, Afghanistan
View Trial DetailsNCT04861506
Cardiovascular Diseases, Efficacy, Self
Hangzhou, Zhejiang, China
View Trial Details