A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called amphotericin B cholesterol-sulfate complex (ABCD) for patients with invasive fungal disease, a serious infection that can occur in people with certain blood cancers like leukemia or lymphoma. The study will involve patients who are at least 18 years old, have low levels of a type of white blood cell called neutrophils (which help fight infections), and have a fever that suggests a fungal infection, even after receiving other treatments. Participants will receive ABCD for 14 days while continuing to be treated for their underlying health issues.

If someone is eligible and agrees to take part in the trial, they can expect to receive this new treatment and be closely monitored for any effects it has on their condition. However, certain individuals, such as those with severe allergies to the drug or those who are pregnant, cannot participate. This study is important because it aims to provide valuable information about the effectiveness and safety of ABCD, which may help improve treatment options for patients facing these challenging infections in the future.

Gender

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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.