Clinical trial NCT06376201: A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease
Official title: A Clinical Study on the Efficacy and Safety of Amphotericin B Cholesteryl Sulfate Complex for Injection in the Empirical First-line Treatment of Patients With Invasive Fungal Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Invasive Fungal Disease
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed.


Eligibility criteria: Inclusion Criteria:

1. Age≥ 18 years old, gender is not limited;
2. Patients with hematologic malignancies such as leukemia and lymphoma who have undergone chemotherapy or hematopoietic stem cell transplantation;
3. Peripheral blood absolute neutrophil count (ANC) \< 0.5×109/L, or expected ANC \< 0.5×109/L after 48 h;
4. Within 48 hours before the screening, at least 2 oral temperature measurements (with an interval of more than 30 minutes) ≥ 38.3°C (axillary temperature≥38.0°C), or ≥ 38°C (axillary temperature≥37.7°C) for more than 1h;
5. Received broad-spectrum antimicrobial therapy for at least 96 hours before screening but still had recurrent or persistent fever and suspected fungal infection;
6. The patient or his/her legal representative signs the informed consent form.

Exclusion Criteria:

1. Those who are allergic to amphotericin class B drugs or any component of the cholesterol-sulfate complex;
2. Patients with clinical suspicion of invasive fungal disease who have received antifungal therapy;
3. Patients with clinically diagnosed or confirmed invasive fungal disease (IFD) during the screening period;
4. Patients with abnormal liver function, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), or ALT or AST \> 3 times ULN and total bilirubin \> 1.5 times ULN;
5. Patients with reduced renal function, who need or are currently undergoing hemodialysis or peritoneal dialysis;
6. Clinically significant hypokalemia (defined as serum potassium \< 3.2 mmol/L, or blood potassium lower than the lower limit of normal while receiving digitalis therapy), and hypokalemia cannot be corrected before starting trial treatment;
7. Expected survival time\< 3 months;
8. Pregnant women, lactating women, or women of childbearing age who have not taken contraceptive measures and are planning to become pregnant;
9. Other investigators believe that it is not appropriate to participate in clinical trials.

Primary outcomes:
measure: Treatment is effective
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of the single index in the five criteria of treatment success
timeFrame: 12 months
measure: Completion rate of ABCD treatment for at least 14 days
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
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