Reducing antibiotic use for patients with neutropenic fever after stem cell transplantation
Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04270786 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with documented infections, septic shock, or allergies to levofloxacin may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.