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

Invasive Fungal Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376201
• Other study ID #: NFEC-2024-018
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Liu Qifa
• Phone: 020-61641615
• Email: liuqifa628[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: September 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Fungal Disease
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Amphotericin B cholesterol-sulfate complex for injection
Patients were eligible for enrollment on antifungal therapy with injectable amphotericin B cholesterol-sulfate complex (ABCD) at the same time as a treatment for underlying disease. Dosage: According to the patient's condition and the investigator's judgment, the initial dose of ABCD can be 0.5-1.0mg/kg/d, and the dose can be increased daily according to the situation, and the therapeutic dose can be increased to 3.0-4.0mg/kg/d on the third day. Course of treatment: = 14 days (whether to continue to receive trial drug treatment after 14 days is decided by the investigator according to the patient's condition).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

References & Publications (9)

Bowden R, Chandrasekar P, White MH, Li X, Pietrelli L, Gurwith M, van Burik JA, Laverdiere M, Safrin S, Wingard JR. A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergi — View Citation

Chinese Association Hematologists; Chinese Invasive Fungal Infection Working Group. [The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision)]. Zhonghua Nei K — View Citation

Dong lu Zhao,Jun Ma. Guiding principle for the administration of amphotericin B colloidal dispersion for injection[J].Journal of Clinical Hematology, 2022, 35(5):6. DOI : 10.13201 / j.issn.1004-2806.2022.05.001.

Dupont B. Clinical efficacy of amphotericin B colloidal dispersion against infections caused by Candida spp. Chemotherapy. 1999 Jun;45 Suppl 1:27-33. doi: 10.1159/000048467. — View Citation

Gurwith M. Clinical efficacy of amphotericin B colloidal dispersion against infections caused by Aspergillus spp. Chemotherapy. 1999 Jun;45 Suppl 1:34-8. doi: 10.1159/000048468. — View Citation

Herbrecht R, Letscher-Bru V, Bowden RA, Kusne S, Anaissie EJ, Graybill JR, Noskin GA, Oppenheim, Andres E, Pietrelli LA. Treatment of 21 cases of invasive mucormycosis with amphotericin B colloidal dispersion. Eur J Clin Microbiol Infect Dis. 2001 Jul;20( — View Citation

Sun Y, Huang H, Chen J, Li J, Ma J, Li J, Liang Y, Wang J, Li Y, Yu K, Hu J, Jin J, Wang C, Wu D, Xiao Y, Huang X. Invasive fungal infection in patients receiving chemotherapy for hematological malignancy: a multicenter, prospective, observational study i — View Citation

Sun Y, Meng F, Han M, Zhang X, Yu L, Huang H, Wu D, Ren H, Wang C, Shen Z, Ji Y, Huang X. Epidemiology, management, and outcome of invasive fungal disease in patients undergoing hematopoietic stem cell transplantation in China: a multicenter prospective o — View Citation

White MH, Bowden RA, Sandler ES, Graham ML, Noskin GA, Wingard JR, Goldman M, van Burik JA, McCabe A, Lin JS, Gurwith M, Miller CB. Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatmen — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment is effective	A patient is considered successful if they meet the following five criteria: Starting antifungal treatment until no new fungal infections occur within 7 days after discontinuation of medication; Patient survival within 7 days after discontinuation of treatment; During the treatment period, the drug was not stopped due to side effects or lack of efficacy; After starting antifungal therapy, patients experience fever reduction during neutropenia (defined as body temperature<38 ? for more than 48 hours); Invasive fungal diseases diagnosed or clinically diagnosed (baseline fungal infection refers to fungal infection confirmed within 24-48 hours after initiation of antifungal treatment) achieve complete or partial efficacy at the end of treatment.; Refer to the "Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Diseases/Malignant Tumors (Sixth Revised Edition)" for the evaluation criteria for the treatment efficacy.	12 months
Secondary	Incidence of the single index in the five criteria of treatment success	The incidence of a single indicator among the five criteria for treatment success mentioned in "Outcome 1"	12 months
Secondary	Completion rate of ABCD treatment for at least 14 days	Completion rate of ABCD treatment for at least 14 days	12 months

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