Status:
RECRUITING
Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.
Lead Sponsor:
Shanxi Bethune Hospital
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
18-75 years
Brief 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 ...
Detailed Description
This study is a single-arm, open-label, observational clinical investigation focusing on patients with hematological malignancies complicated by febrile neutropenia. It aims to evaluate the overall ef...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 22 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07204522
Start Date
September 22 2025
End Date
September 22 2027
Last Update
October 2 2025
Active Locations (1)
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1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000