- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270786
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
November 23, 2021 updated by: Jiong HU, Shanghai Jiao Tong University School of Medicine
Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ling Wang
- Phone Number: 601878 86-21-64370045
- Email: cclingjar@163.com
Study Contact Backup
- Name: Jiong HU
- Phone Number: 86-21-64370045
- Email: hj10709@rjh.com.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Blood & Marrow Transplantation Center, RuiJin Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.
|
Other: Standard
In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice.
|
In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Anticipated)
December 30, 2021
Study Completion (Anticipated)
December 30, 2021
Study Registration Dates
First Submitted
February 13, 2020
First Submitted That Met QC Criteria
February 13, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 23, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-BMT-Antibio
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Safety Issues
-
Fundacion Clinica Valle del LiliRecruiting
-
Nanjing Immunophage Biotech Co., LtdRecruiting
-
Xian-Jun YuNot yet recruiting
-
Hsieh-Hsun HoCompleted
-
Gadjah Mada UniversityActive, not recruitingSafety IssuesIndonesia
-
Equilibre Biopharmaceuticals B.V.CompletedSafety IssuesUnited States
-
Federal University of BahiaCompleted
-
Hospital Universitario Dr. Jose E. GonzalezCompleted
-
Niconovum USAInflamax Research IncorporatedCompletedSafety IssuesUnited States
-
Ente Ospedaliero Cantonale, BellinzonaCompleted
Clinical Trials on Early de-escalation
-
Chiang Mai UniversityCompletedAnti-Bacterial Agents
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; Stichting tegen KankerRecruitingSquamous Cell Carcinoma of Head and NeckBelgium
-
Region SkaneExact Sciences CorporationRecruiting
-
British Columbia Cancer AgencyCompletedEndometrial CancerCanada
-
University Medical Centre MariborCompletedAggression | Education | Physical RestraintSlovenia
-
Bergen University CollegeHelse-Bergen HFCompleted
-
Royal North Shore HospitalNot yet recruitingHPV Positive Oropharyngeal Squamous Cell CarcinomaAustralia
-
Technische Universität DresdenGerman Cancer Research Center; National Center for Tumor Diseases, Heidelberg; Radiation Oncology Working Group of the German Cancer Society and other collaboratorsRecruitingHead-and-neck Squamous Cell CarcinomaGermany
-
National Cancer Institute, EgyptRecruitingHead and Neck CarcinomaEgypt
-
Universitaire Ziekenhuizen KU LeuvenUniversity Hospital, GhentCompleted