An observational study in Febrile Neutropenia, sponsored by Shanxi Bethune Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Shanxi Bethune Hospital · Observational
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.
This study is a single-arm, open-label, observational clinical investigation focusing on patients with hematological malignancies complicated by febrile neutropenia. It aims to evaluate the overall efficacy and safety of a standardized empirical anti-infective treatment algorithm. The protocol employs a unified step-up therapeutic strategy: initial empirical administration of a carbapenem antibiotic (for 2 days); if ineffective, combination with an anti-Gram-positive agent (e.g., vancomycin or linezolid) (for 3 days); if there is still no response, initiation of antifungal therapy (for 7 days); For patients exhibiting persistent or recurrent fever with uncontrolled infection-related parameters after 12-14 days of prior empirical anti-infective therapy, an empirical multidrug-resistant regimen consisting of ceftazidime-avibactam combined with aztreonam is considered. The treatment duration will be adjusted based on neutrophil recovery and febrile status. The study will assess overall efficacy through a comprehensive evaluation of clinical symptoms and signs, inflammatory biomarkers (e.g., C-reactive protein, procalcitonin), radiographic findings, and microbiological results. Safety monitoring will include continuous surveillance of adverse events (AEs) and all-cause mortality throughout the treatment course.
151 studies on the registry are indexed under Febrile Neutropenia; 33 are open to participants now.
This study's planned enrollment of 20 is below the median of 131 across 56 observational studies indexed under Febrile Neutropenia.
Browse Febrile Neutropenia studies →Shanxi Bethune Hospital is the lead sponsor of 21 studies on the registry; 20 are open to participants now.
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This single-arm, open-label, observational study will enrol adult patients with haematological malignancies who develop febrile neutropenia and are scheduled to receive empirical ceftazidime-avibactam. Eligible participants are aged 18-75 years with acute leukaemia, severe aplastic anaemia, lymphoma or multiple myeloma, an absolute neutrophil count \< 0.5 × 10⁹/L (or expected to fall below this within 48 h), fever ≥ 38.3 °C, ECOG performance status 0-2, and no contraindications such as drug fever, intracranial haemorrhage, pregnancy, or QTc > 500 ms. The cohort will reflect the real-world haematology ward population at high risk for multidrug-resistant Gram-negative infections.
Exclusion Criteria:
First-line empirical agent for febrile neutropenia complicating hematologic malignancies: carbapenem.
Escalation to a carbapenem plus an anti-Gram-positive agent (vancomycin or linezolid) is instituted if no defervescence occurs after 48h of first-line therapy; this combination is maintained for 3 days before further escalation in febrile-neutropenia patients with underlying hematologic malignancies.
If combination therapy with a carbapenem plus an anti-Gram-positive agent (vancomycin or linezolid) remains ineffective after 72 h, empirical antifungal coverage is added while continuing antibacterial therapy for an additional 7 days; failure to defervesce thereafter mandates further therapeutic escalation in febrile-neutropenic patients with hematologic malignancies.
If the combination of a carbapenem and an anti-Gram-positive agent (vancomycin or linezolid) fails to achieve defervescence after 3 days of treatment, an antifungal agent is added while continuing the original antibacterial regimen for an additional 7 days. Should fever persist or recur with uncontrolled infection-related parameters after 12-14 days of empirical anti-infective therapy, the carbapenem/anti-Gram-positive combination is discontinued. Therapy is then switched to ceftazidime-avibactam plus aztreonam to cover multidrug-resistant pathogens, while concurrently maintaining antifungal treatment. This escalation strategy is indicated for febrile neutropenic patients with underlying hematologic malignancies.
Symptom Resolution Rate by Patient-Reported Temperature Diary
Proportion of patients achieving defervescence (oral temperature \< 38 °C sustained for ≥ 8 h) AND absence of infection-related symptoms recorded in a validated patient diary within 48 h after starting empirical therapy.
Time frame: two days
C-Reactive Protein Serum Concentration Change (mg/L)
Absolute decrease from baseline in high-sensitivity CRP measured by immunoturbidimetric assay at 48 h.
Time frame: two days
Procalcitonin Plasma Concentration Change (ng/mL)
Absolute decrease from baseline in PCT measured by electrochemiluminescence immunoassay at 48 h.
Time frame: Two days
Pulmonary Infiltrate Resolution on CT or Chest X-ray
Proportion of patients with ≥ 50 % reduction in the longest diameter of any lung infiltrate compared with baseline scan.
Time frame: Two weeks
Pathogen Positivity Rate in Blood or Sterile-Site Cultures
Cumulative proportion of patients with clinically relevant bacteria or fungi isolated from blood or other normally sterile sites processed by automated BACTEC™ culture system.
Time frame: one week
Physical Sign Resolution Score by Clinician Examination
Proportion of patients in whom predefined signs (erythema, tenderness, exudate, etc.) disappear or improve by ≥ 50 % on a 4-point clinician-graded scale.
Time frame: two days
First-Line Carbapenem Clinical Success Rate
Proportion achieving defervescence AND ≥ 50 % CRP decrease at 72 h on carbapenem monotherapy.
Time frame: three days
Carbapenem Plus Anti-Gram-Positive Agent Clinical Success Rate
Proportion achieving defervescence AND ≥ 50 % CRP decrease at 72 h after adding vancomycin or linezolid.
Time frame: three days
Antifungal Therapy Biomarker Response Rate
Proportion with ≥ 50 % reduction in serum galactomannan (Platelia™ ELISA) or β-D-glucan (Fungitell™) at 72 h post-antifungal initiation.
Time frame: three days
CRE/MDR-GNB Eradication Rate After CAZ-AVI Plus Aztreonam
Proportion of patients with documented CRE/MDR-GNB whose follow-up blood or sterile-site culture becomes negative within 72 h of starting ceftazidime-avibactam plus aztreonam.
Time frame: three days
Incidence of Adverse Events Assessed by CTCAE v5.0 (Entire Course)
Number and grade of drug-related cardiac, hepatic, renal, or allergic adverse events captured through CTCAE v5.0 forms.
Time frame: From first antimicrobial dose to 30 days post-therapy
All-Cause Mortality Rate
Proportion of participants who die from any cause within 30 days after enrolment.
Time frame: 30 days
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Shanxi Bethune Hospital