Safety IssuesNCT04270786
Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever
A study testing Early de-escalation and Standard in people with Safety Issues, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Safety Issues
- What is being tested?
- Early de-escalation and Standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, 200025
Jiong HU, M.D.,, 86-21-64370045, hujiong@medmail.com.cn
Ling Wang, M.D.,, 86-21-64370045, cclingjar@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- Early de-escalation, Standard
- Keywords
- neutropenic fever, empiric, antibiotics
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early de-escalationProcedure or surgery
In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.
StandardProcedure or surgery
In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.
| Study group | Role | What they receive |
|---|---|---|
| Early de-escalation | Experimental | In the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours. Receives: Procedure: Early de-escalation |
| Standard | Other | In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice. Receives: Procedure: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of no empirical antibiotics treatment
days from start of empirical antibiotics to end of study minus days with empirical antibiotics
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Jan 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiong hu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270786
- Sponsor's protocol ID
- 2019-BMT-Antibio
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2020
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04270786
- Acronym / sponsor ID
- 2019-BMT-Antibio
- Conditions
- Safety Issues
- Keywords
- neutropenic fever, empiric, antibiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early de-escalation | Experimental | Procedure: Early de-escalationIn the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours. |
| Standard | Other | Procedure: StandardIn the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early de-escalationIn de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed. | Procedure or surgery | Early de-escalation |
| StandardIn the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile. | Procedure or surgery | Standard |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiong hu principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early de-escalation and Standard in people with Safety Issues, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling Wang (86-21-64370045 ext. 601878, cclingjar@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of no empirical antibiotics treatment (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.