Clinical Trial

Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.

Recruiting
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Summary
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.
Trial Details
NCT Number NCT07204522
Lead Sponsor Shanxi Bethune Hospital
Conditions Febrile Neutropenia
Enrollment 20 participants
Start Date 2025-09-22
Primary Completion 2027-09-22 (estimated)
Study Completion 2027-09-22 (estimated)
Updated on ClinicalTrials.gov 2025-10-02