A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus (NCT05707832) | Clinical Trial Compass
CompletedPhase 3
A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus
China31 participantsStarted 2023-03-30
Plain-language summary
This is a multi-center, open-label, non-controlled, single-arm clinical trial to evaluate the safety, efficacy and population pharmacokinetics of Amphotericin B cholesteryl Sulfate Complex for Injection domestic formulations (ABCD) in the treatment of confirmed invasive candidiasis (IC) and confirmed/clinically diagnosed invasive aspergillus (IA) disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years old, male or female;
. Subjects who meet the EORTC-MSG diagnostic criteria and are diagnosed with invasive candidiasis (confirmed) or invasive aspergillus disease (confirmed or clinical) according to the Revised Definition of Invasive Mycosis: IC confirmed subjects are positive candida culture reports from blood or other sterile samples obtained within 48 hours prior to enrollment; Or the histopathological/cytopathological examination report of needle aspiration or biopsy specimens from normal sterile except mucosa within 2 weeks showed the presence of candida; IA confirmed subjects are defined as diseased tissue (sterile sampling) obtained within 4 weeks prior to enrollment with definite fungal presence (cytology, microscopy, or culture, etc.). The clinical diagnosis of IA includes at least one host factor, one clinical criterion, and one microbiological criterion (serum, sputum, bronchoalveolar lavage fluid, bronchial brush specimen, or sinus extract indicating positive Aspergillus GM test);
. All subjects agreed to use contraception from the time signed the informed consent to 6 weeks after the end of the last dose;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number and percentage of subjects whose treatment is terminated due to study abnormal laboratory tests leads to drug related adverse events.
Timeframe: From Day 1 to the end of treatment, no more than 6 weeks.
2
The number and percentage of subjects whose treatment is terminated due to study the infusion reaction leads to drug related adverse events.
Timeframe: From Day 1 to the end of treatment, no more than 6 weeks.
3
The number and percentage of subjects with study the infusion reaction leads to drug related adverse events.
Timeframe: From Day 1 to the end of treatment, no more than 8 weeks.
4
The number and percentage of subjects with study abnormal laboratory tests leads to drug related adverse events.
Timeframe: From Day 1 to the end of treatment, no more than 8 weeks.
. Female subjects must meet one of the following conditions: have surgical sterilization; postmenopausal, menopause at least 1 year; or for those with fertility, must satisfy the following conditions: negative human chorionic gonadotropin (HCG) serum test results prior to enrollment; avoidance of sexual behavior throughout the study period, or agreement to use a recognized and highly effective contraceptive measure \[defined as being able to be used consistently and correctly with a failure rate of less than 1% per year, such as: condoms, combined hormones (including estrogen and progesterone) combining inhibit ovulation, progestin contraception combined with ovulation suppression, intrauterine device (IUD), intrauterine hormone release system (IUS), bilateral tubal ligation, bilateral vasectomy\], and the contraceptive methods remained unchanged throughout the study period;
. Male subjects must have been surgically sterilized or their female partners must have met any of #4 above, and their contraceptive methods remained unchanged during the study period;
. Subjects and/or guardian fully understand, voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
. Allergic to amphotericin B drugs or cholesterol sulfate complex antifungal drugs;
. IC subjects received systemic antifungal therapy for ≥3 days within 1 week prior to enrollment (subjects with no improvement in symptoms of infection after treatment or with positive blood culture candida can still be enrolled; Subjects with neutropenia can use triazole prophylaxis for an unlimited days);
. IA subjects received systemic antifungal therapy for more than 96 hours within 1 week prior to enrollment (subjects with no improvement in symptoms of infection after treatment or those with positive microbiological criteria can still be enrolled), or prophylactic therapy for more than 13 days or common amphotericin B with cumulative dose of more than 10 mg/kg within 10 days prior to enrollment, or use amphotericin lipids with a cumulative dose of more than 15 mg/kg;
. Evidence of infection in subjects is limited to positive candida cultures in urine (other than those diagnosed with pyelonephritis), sputum and bronchoalveolar lavage fluid, catheter tops, drainage fluid, or other mucous membranes or superficial skin surfaces (e.g. vagina or other external genitalia, colon, oropharynx, esophagus, skin folds, nail beds, etc.);
. Subjects with suspected candida endocarditis, osteomyelitis, arthritis, endophthalmitis, liver and spleen abscess, suppurative thrombophlebitis, or central nervous system infection;
. Candida culture positive samples collected 24 hours after the non first placement of the catheter or drainage tube at the sterile site;
. Intravenous catheterization is associated with aggressive candidiasis in subjects whose catheters could not be removed or replaced during the study period;
. Subjects with chronic pulmonary aspergillus disease (duration ≥3 months), aspergilloma or allergic bronchopulmonary aspergillus disease;