Reducing antibiotic use for patients with neutropenic fever after stem cell transplantation
Official title: Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
Run by Shanghai Jiao Tong University School of Medicine · NCT04270786 · Data updated 2026-11-12
This study is testing if stopping antibiotics early is safe for patients with neutropenic fever after stem cell transplantation who have been fever-free for 72 hours.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2020 |
| Main results expected | December 30, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT04270786 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are undergoing HSCT and have developed neutropenic fever but have become afebrile for at least 72 hours.
✕Probably not a fit
Patients with documented infections, septic shock, or allergies to levofloxacin may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized study evaluates the safety and feasibility of stopping empirical antibiotic treatment early in patients with neutropenic fever who are undergoing hematopoietic stem cell transplantation (HSCT). Patients who remain afebrile for 72 hours after starting antibiotics will be divided into two groups: one will stop antibiotics and resume levofloxacin prophylaxis, while the other will continue antibiotics until recovery from neutropenia or for at least 7 days. The goal is to determine if early de-escalation is a safe and effective approach.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary antibiotic exposure and associated side effects for patients undergoing HSCT.
How similar studies have gone: While the approach of early de-escalation in antibiotic treatment is being explored, this specific methodology in HSCT patients is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Blood & Marrow Transplantation Center, RuiJin Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Jiong hu — Ruijin Hospital
- Study coordinator: Ling Wang
- Email: cclingjar@163.com
- Phone: 86-21-64370045
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SSS55 safety and how the body handles it in healthy adults
This trial tests a single injection of SSS55 in healthy adults to see if it is safe, how the body processes it, and whether it triggers immune responses.
-
Be SMART secure firearm storage counseling for hospitalized caregivers
This program will test whether a short Be SMART video and handout help caregivers of hospitalized children store firearms more safely at home.
-
Registry for patients undergoing coronary intervention with orbital atherectomy
This study is collecting information on patients with hard-to-treat heart blockages who are getting a specific procedure called orbital atherectomy to see how safe and effective it is.
-
Evaluation of a new bone graft substitute for tooth extraction sites
This study is testing a new bone graft substitute called Wishbone HA to see if it works as well as a standard option for helping people heal after tooth extractions.
-
Registry for patients with refractory angina undergoing Coronary Sinus Reducer implantation
This study is testing if a new device called the Coronary Sinus Reducer can help people with severe chest pain who haven't found relief from other treatments.
-
Evaluating bifurcation coronary interventions using two techniques
This study looks at how well two different stenting techniques work for patients with heart artery blockages to see which one is safer and more effective.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.