Actively Recruiting
Observational Study on the Efficacy of Empirical Antimicrobial Therapy in Febrile Neutropenia
Led by Shanxi Bethune Hospital · Updated on 2025-10-02
20
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a stepwise empirical anti-infective treatment for patients with blood cancers who develop febrile neutropenia, a condition involving fever and low white blood cell count. This open-label, single-arm clinical study focuses on a standardized treatment protocol that escalates therapy based on patient response. The study includes monitoring clinical symptoms, inflammatory markers, imaging results, and microbiological tests to assess treatment success. The treatment starts with carbapenem antibiotics given for 2 days. If fever persists, vancomycin or linezolid is added for 3 days. If there is still no improvement, antifungal therapy is introduced for 7 days. For patients with ongoing fever and uncontrolled infection after 12 to 14 days, the protocol switches to a combination of ceftazidime-avibactam and aztreonam. Treatment duration may be adjusted according to neutrophil recovery and fever status. Participants will undergo regular assessments including temperature monitoring, blood tests for inflammatory markers like C-reactive protein and procalcitonin, chest imaging to check lung infections, and microbiological cultures to identify pathogens. Safety is closely tracked through continuous monitoring of adverse events and mortality during the treatment course. The study aims to provide detailed data on symptom resolution and infection control over the therapy period.
CONDITIONS
Brief Title
Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years.
- Diagnosis of hematological malignancy such as acute leukemia, severe aplastic anemia, lymphoma, or multiple myeloma.
- Neutropenia with absolute neutrophil count below 0.5 x 10⁹/L or expected to fall below this within 48 hours.
- Fever defined as a single oral temperature of at least 38.3°C or sustained oral temperature of at least 38.0°C for more than one hour.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Planned or current empirical use of ceftazidime-avibactam for febrile neutropenia.
You will not qualify if you...
- Fever caused by drug reaction or rheumatic/autoimmune disease.
- Presence of intracranial hemorrhage.
- Pregnancy, breastfeeding, or intention to become pregnant.
- Psychiatric disorder or any condition preventing study compliance.
- Life-threatening arrhythmia or QTc interval greater than 500 ms on electrocardiography.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 to 14 days or until neutrophil recovery and fever resolution
Participants receive a step-up empirical anti-infective therapy starting with carbapenem antibiotics, with escalation to combination therapy with anti-Gram-positive agents, antifungal therapy, and if needed, multidrug-resistant regimen including ceftazidime-avibactam plus aztreonam, based on response.
Daily visits during treatment period
Duration - 30 days post-therapy
Participants are monitored for safety including adverse events and all-cause mortality for up to 30 days after completing treatment.
Regular monitoring visits during follow-up
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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