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

April 16, 2024 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amphotericin B cholesterol-sulfate complex (ABCD)

Investigational drug: 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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment is effective
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of the single index in the five criteria of treatment success
Time Frame: 12 months
The incidence of a single indicator among the five criteria for treatment success mentioned in "Outcome 1"
12 months
Completion rate of ABCD treatment for at least 14 days
Time Frame: 12 months
Completion rate of ABCD treatment for at least 14 days
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2024-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A summary report will be written and published after the clinical trial is completed, and the data from the summary report or article will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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