Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients. (NCT07204522) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.
China20 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptom Resolution Rate by Patient-Reported Temperature Diary
Timeframe: two days
2
C-Reactive Protein Serum Concentration Change (mg/L)
Timeframe: two days
3
Procalcitonin Plasma Concentration Change (ng/mL)
Timeframe: Two days
4
Pulmonary Infiltrate Resolution on CT or Chest X-ray
Timeframe: Two weeks
5
Pathogen Positivity Rate in Blood or Sterile-Site Cultures
Timeframe: one week
6
Physical Sign Resolution Score by Clinician Examination