Stepwise antibiotic and antifungal treatment for febrile neutropenia in blood cancer patients
Official title: Observational Study on the Efficacy of Empirical Antimicrobial Therapy in Febrile Neutropenia.
Run by Shanxi Bethune Hospital · NCT07204522 · Data updated 2026-11-12
This treatment plan tests whether a stepwise escalation of antibiotics and antifungals can control infection and fever in adults with hematologic malignancies who develop febrile neutropenia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Shanxi Bethune Hospital Academic / other |
| Locations | 1 site (Taiyuan, Shanxi) |
| Status | Recruiting |
| Started | September 22, 2025 |
| Main results expected | September 22, 2027 |
| Study ends | September 22, 2027 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT07204522 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 with documented hematologic malignancy and febrile neutropenia (ANC < 0.5 × 10^9/L or expected to fall below this within 48 hours), ECOG 0–2, and planned or current empirical use of ceftazidime–avibactam.
✕Probably not a fit
Patients whose fever is due to noninfectious causes (such as drug- or autoimmune-related fever) or who have contraindications like intracranial hemorrhage, pregnancy, severe arrhythmia, or inability to comply with the protocol are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm, open-label observational study applies a standardized empirical escalation algorithm for adult hematologic malignancy patients who develop febrile neutropenia. Patients begin with carbapenem monotherapy for 2 days, add an anti–Gram-positive agent (vancomycin or linezolid) for 3 days if needed, then proceed to antifungal therapy for 7 days if fever persists, and consider ceftazidime–avibactam plus aztreonam for persistent or recurrent fever after 12–14 days. Efficacy is judged by clinical signs, inflammatory biomarkers (e.g., CRP, procalcitonin), radiographic imaging, and microbiology, and treatment duration is adapted to neutrophil recovery and febrile status. Continuous safety monitoring captures adverse events and all-cause mortality throughout the treatment course.
Why it matters
Potential benefit: If successful, this protocol could provide a clear escalation pathway that shortens time to effective therapy and reduces uncontrolled infections and related complications in neutropenic patients.
How similar studies have gone: Stepwise empirical escalation is an established approach in febrile neutropenia with mixed outcomes, while using ceftazidime–avibactam plus aztreonam for refractory multidrug-resistant infections is a newer strategy with limited but growing supporting evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years. * Documented haematological malignancy: acute leukaemia, severe aplastic anaemia, lymphoma, or multiple myeloma. * Neutropenia: absolute neutrophil count (ANC) \< 0.5 × 10⁹/L, or ANC anticipated to fall below this threshold within 48 h; severe neutropenia defined as ANC \< 0.1 × 10⁹/L. * Fever: single oral temperature ≥ 38.3 °C (axillary ≥ 38.0 °C), or oral temperature ≥ 38.0 °C (axillary ≥ 37.7 °C) sustained for \> 1 h. * Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2. * Planned or current empirical use of ceftazidime-avibactam (CAZ-AVI) for febrile neutropenia. Exclusion Criteria: * Drug-related fever or fever attributable to rheumatic/autoimmune disease. * Concomitant intracranial haemorrhage. * Pregnancy, lactation, or intention to become pregnant. * Psychiatric disorder or any condition precluding protocol compliance. * Life-threatening arrhythmia or QTc \> 500 ms on electrocardiography.
Where it's running
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Shanxi Bethune Hospital
Taiyuan, Shanxi, China Recruiting
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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.