Observational Study on the Efficacy of Empirical Antimicrobial Therapy in Febrile Neutropenia.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• 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.

Locations
Other Locations
China
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2027-09-22
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Shanxi Bethune Hospital

This content was sourced from clinicaltrials.gov