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

Recruitingn/aAges 18 Years - 75 YearsAllShanxi Bethune Hospital
NCT07204522 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 mo

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📋 Eligibility rules (as published)
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.
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What it tests

  • Carbapenems
  • Anti-Gram-positive agent
  • Antifungal agent
  • Ceftazidime-avibactam + Aztreonam
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Where

1 site
Shanxi Bethune Hospital
Taiyuan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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