Acute Leukemia with Chemotherapy-Induced Febrile Neutropenia
Conditions
Interventions
Research group(Eravacycline-Based Combination Antibiotic Regimens):None
Control group:None
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Clinically diagnosed with any type of acute leukemia (diagnosis based on Chinese leukemia diagnosis and treatment guidelines and expert consensus); 3.Confirmed febrile neutropenia (FN) as defined in the Chinese Guidelines for the Clinical Use of Antimicrobial Agents in Patients with Febrile Neutropenia (2020 Edition): (1) Neutropenia defined as absolute neutrophil count (ANC) = 38.3 °C (axillary temperature >= 38.0 °C), or oral temperature >= 38.0 °C (axillary temperature >= 37.7 °C) lasting more than 1 hour. Patients with FN infection who may lack fever or present with hypothermia based on clinical judgment (e.g., elderly or ICU patients) may also be included. 4.High-risk patients meeting any of the following criteria according to the Chinese Guidelines for the Clinical Use of Antimicrobial Agents in Patients with Febrile Neutropenia (2020 Edition): (1) Expected severe neutropenia ( 7 days (2) Any of the following clinical comorbidities (including but not limited to): 1). Hemodynamic instability; 2). Oral or gastrointestinal mucositis with dysphagia; 3). Gastrointestinal symptoms (abdominal pain, nausea, vomiting, diarrhea); 4). New-onset neurological changes or psychiatric symptoms; 5).Intravascular catheter infections, especially catheter lumen infections;6).New pulmonary infiltrates or hypoxemia, or underlying chronic lung disease. (3) Hepatic insufficiency (transaminase levels > 5× upper limit of normal) or renal insufficiency (creatinine clearance < 30 ml/min) (4) Concurrent immunocompromising disease (5) Receiving molecular targeted therapy or immunomodulatory therapy 5.Failure of initial empirical antibiotic therapy (EAT), defined as no improvement of infection after at least 48–72 hours of initial carbapenem antibiotic therapy for febrile neutropenia or suspected infection; 6.Signed informed consent from the subject or their legally authorized representative in the eravacycline group.
Exclusion criteria
Exclusion criteria: 1.Non-Chinese population (defined as those whose biological parents and grandparents are all of Chinese descent); 2.History of hypersensitivity reaction to tetracyclines or any excipient contained in the study drug formulation; 3.Exposure to the study drug (eravacycline or tigecycline) for < 72 hours; 4.Currently participating in another clinical trial of a drug or device (interventional clinical study); 5.Any other reason deemed by the investigator to make the subject unsuitable for study observation and data collection (e.g., severe missing data that cannot meet baseline assessment and outcome evaluation requirements, inability to complete follow-up and clinical assessments); 6.Confirmed infection due to Pseudomonas aeruginosa alone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate at the Test-of-Cure (TOC) assessment (14 days after end of treatment) for eravacycline-based or tigecycline-based combination antibiotic therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial eradication rate at TOC for eravacycline-based or tigecycline-based combination antibiotic therapy;Clinical response rate at end of treatment (EOT) for eravacycline-based or tigecycline-based combination antibiotic therapy;Bacterial eradication rate at EOT for eravacycline-based or tigecycline-based combination antibiotic therapy;Early clinical response rate for eravacycline-based or tigecycline-based combination antibiotic therapy;Time from initiation of eravacycline-based or tigecycline-based combination antibiotic therapy to early clinical response (time to defervescence);All-cause mortality within 30 days after initiation of eravacycline-based or tigecycline-based combination antibiotic therapy;Adverse events, adverse events related to study drug exposure, adverse events leading to discontinuation of study drug exposure, serious adverse events; | — |
Countries
China
Contacts
Public ContactZhang Xi
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed