Actively Recruiting
Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.
Led by Shanxi Bethune Hospital · Updated on 2025-10-02
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-arm, open-label clinical study evaluates the efficacy and safety of a standardized empirical anti-infective escalation protocol for patients with hematological malignancies complicated by febrile neutropenia. The treatment algorithm follows a sequential strategy: initial carbapenem monotherapy (2 days) → if ineffective, combination with vancomycin/linezolid (3 days) → if no response, escalation to antifungal therapy (7 days). For patients demonstrating persistent or recurrent fever with uncontrolled infection parameters after 12-14 days of prior empirical anti-infective therapy, switching to ceftazidime-avibactam combined with aztreonam is implemented. Therapeutic efficacy is assessed through comprehensive evaluation of clinical manifestations, inflammatory biomarkers, radiographic imaging, and microbiological findings. Comprehensive safety surveillance includes continuous monitoring of adverse events and all-cause mortality throughout the treatment course.
CONDITIONS
Official Title
Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with a hematological malignancy such as acute leukemia, severe aplastic anemia, lymphoma, or multiple myeloma
- Absolute neutrophil count less than 0.5 × 10⁹/L or expected to fall below this within 48 hours; severe neutropenia defined as less than 0.1 × 10⁹/L
- Fever defined as a single oral temperature of 38.3°C or higher (axillary 38.0°C or higher), or oral temperature of 38.0°C or higher (axillary 37.7°C or higher) sustained for over 1 hour
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Planned or current empirical use of ceftazidime-avibactam for febrile neutropenia
You will not qualify if you...
- Fever caused by drugs or rheumatic/autoimmune diseases
- Presence of intracranial hemorrhage
- Pregnancy, breastfeeding, or planning to become pregnant
- Psychiatric disorders or any condition preventing following the study protocol
- Life-threatening heart rhythm problems or QTc interval over 500 ms on ECG
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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