NCT07204522 Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.
| NCT ID | NCT07204522 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanxi Bethune Hospital |
| Condition | Febrile Neutropenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2027-09-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-09-22 with a primary completion date of 2027-09-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Frequently Asked Questions
Who can join the NCT07204522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Febrile Neutropenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07204522 currently recruiting?
Yes, NCT07204522 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanxi Bethune Hospital to inquire about joining.
Where is the NCT07204522 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT07204522 clinical trial?
NCT07204522 is sponsored by Shanxi Bethune Hospital. The trial plans to enroll 20 participants.