Invasive CandidiasisPhase 3NCT05707832

A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus

A Phase 3 study testing Amphotericin B cholesteryl Sulfate Complex for Injection in people with Invasive Candidiasis and Invasive Aspergillosis, run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Invasive Candidiasis, Invasive Aspergillosis
What is being tested?: Amphotericin B cholesteryl Sulfate Complex for Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteChina
Study dates: 30 Mar 2023to 31 Mar 2025
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
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.

Who cannot join

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;

Show all 24Show fewer

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;
Subjects are known to have mixed invasive Candida or Aspergillus infections and/or are not sensitive to or resistant to amphotericin B treatment, such as subjects with invasive Aspergillus terreus and Aspergillus nidulans;
Subjects who have been fitted with an artificial device (other than intravenous catheterization) and are suspected of being the source of infection and cannot have the device removed within 24 hours after enrollment;
Subjects with abnormal liver function (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥5 times the upper limit of normal without increase in total bilirubin, or ALT or AST increase 3 times the upper limit of normal with 1.5 times increase in total bilirubin);
Subjects with renal dysfunction who require or are currently undergoing hemodialysis or peritoneal dialysis;
Subjects with clinically significant hypokalemia (defined as serum potassium concentration <3.2 mmol/L, or below the lower limit of normal in subjects undergoing digitalization ) and whose hypokalemia could not be corrected before beginning treatment;
Subjects who plan to use prohibited drugs during the study;
The expected survival time is less than 2 months;
Unstable medical conditions other than diseases of the hematopoietic system, such as disorders or impairment of the heart or nervous system, that are expected to be unstable or progressive over the course of the study (e.g. epilepsy or demyelinating syndrome, acute myocardial infarction, myocardial ischemia or unstable congestive heart failure, unstable arrhythmia, atrial fibrillation with ventricular rate <60/ min, or a history of tip torsion, symptomatic ventricular or persistent arrhythmias within 3 months prior to enrollment)
Degree Ⅱ type 2 or Ⅲ atrioventricular block and long QT syndrome or QTc>470 ms (female) /450 ms (male) on the 12-lead ECG without pacemaker installation;
Subjects with NYHA grade Ⅲ/Ⅳ cardiac function;
HIV antibody positive at first screening;
Pregnant and lactating women;
A history of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) and a history of drug dependence (sedatives, hypnotics, analgesics, narcotics, stimulants, antipsychotics, etc.);
Subjects who have participated in clinical trials of other drugs or medical devices within three months prior to screening (except those who are signed to be informed but not enrolled for drug administration or medical device treatment);
Subjects who have participated in this study (except for prior effective use of this product and after 5 half-lives of this product or 14 days of washout prior to screening);
Not suitable for this study as decided by the investigator due to complicated with severe organ insufficiency, clinically significant laboratory abnormalities, comprehension or compliance problems, etc.

Trial locations and contacts

1 site in 1 country.

China1 site

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: An Open Clinical Trial to Evaluate the Safety, Efficacy and Population Pharmacokinetics of Amphotericin B Cholesteryl Sulfate Complex for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus

Read the detailed description

The study includes a screening period (day -14 to day -1), a baseline period (day 1), a treatment period, and a follow-up period (14±3 days after the end of administration). Eligible subjects will receive intravenous ABCD infusion. A test dose of 2 mg/10 mL will be given at baseline, followed by titration after the evaluation of the subjects' symptoms, signs and tolerance by investigator, until reaching the recommended dose of 3.0-4.0 mg/kg once a day for treatment. IC subjects will receive ABCD intravenous therapy for a minimum of 2 weeks, and a maximum of 14 days after the first negative turn of candida culture in blood or other normal sterile sites and the symptoms and signs of infection disappear/improve significantly, up to a maximum of 6 weeks. IA subjects will be treated with ABCD for at least 2 weeks and up to 6 weeks. After the end of intravenous therapy, according to the individual condition of the subjects, pathogens, drug sensitivity test, and the therapeutic effect of ABCD, the investigator will make a comprehensive judgment on whether to give sequential therapy drugs, but the total course of treatment shall not exceed the duration specified in the above scheme (the number of days of ABCD intravenous therapy plus the number of days of sequential therapy shall not exceed 6 weeks). The study will end when the last subject completed the follow-up period.

Conditions: Invasive Candidiasis, Invasive Aspergillosis
Being tested: Amphotericin B cholesteryl Sulfate Complex for Injection
Medical subject headings: Candidiasis, Invasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amphotericin B cholesteryl Sulfate Complex for InjectionDrug
Intravenous injection (IV), once a day after reaching the recommended dose of 3.0-4.0 mg/kg for treatment. Subjects will receive ABCD intravenous therapy for at least 2 weeks, and the longest course of treatment will not exceed 6 weeks.

Study groups in NCT05707832
Study group	Role	What they receive
Amphotericin B cholesteryl Sulfate Complex for Injection	Experimental	Subjects will receive ABCD intravenous injection. Receives: Drug: Amphotericin B cholesteryl Sulfate Complex for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

The number and percentage of subjects whose treatment is terminated due to study abnormal laboratory tests leads to drug related adverse events.
The number and percentage of subjects whose treatment is terminated due to study abnormal laboratory tests leads to drug related adverse events.
Measured: From Day 1 to the end of treatment, no more than 6 weeks.
The number and percentage of subjects whose treatment is terminated due to study the infusion reaction leads to drug related adverse events.
The number and percentage of subjects whose treatment is terminated due to study the infusion reaction leads to drug related adverse events.
Measured: From Day 1 to the end of treatment, no more than 6 weeks.
The number and percentage of subjects with study the infusion reaction leads to drug related adverse events.
The number and percentage of subjects with study the infusion reaction leads to drug related adverse events.
Measured: From Day 1 to the end of treatment, no more than 8 weeks.
The number and percentage of subjects with study abnormal laboratory tests leads to drug related adverse events.
The number and percentage of subjects with study abnormal laboratory tests leads to drug related adverse events.
Measured: From Day 1 to the end of treatment, no more than 8 weeks.

Secondary outcomes (5)

Population pharmacokinetic characteristics (PPK analysis)
Population pharmacokinetic characteristics (PPK analysis: Population pharmacokinetic characteristics (PPK analysis)Population pharmacokinetic characteristics (PPK analysis:Maximum Plasma Concentration [Cmax])
Measured: From Day 1 to the end of treatment, no more than 8 weeks.
The proportion of subjects who are generally effective
The proportion of subjects who are generally effective.Generally effective means complete remission and partial remission.
Measured: From Day 1 to the end of treatment, no more than 44 days.
Percentage of subjects that are microbiologically valid
Percentage of subjects that are microbiologically valid
Measured: From Day 1 to the end of treatment, no more than 8 weeks.
The proportion of subjects who are generally effective at the end of treatment and relapse at the end of treatment
The proportion of subjects who are generally effective at the end of treatment and relapse at the end of treatment
Measured: From Day 1 to the end of treatment, no more than 8 weeks.
All-cause mortality at 30 days after initiation of ABCD
All-cause mortality at 30 days after initiation of ABCD（Mortality at 30 days postdose was calculated regardless of duration of treatment.）
Measured: From Day 1 to Day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 202331 Mar 2025

First posted1 Feb 2023
Study start30 Mar 2023
Primary completion30 Jul 2024
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05707832
Sponsor's protocol ID: HF114-006
Status last verified: Nov 2022
First submitted: 29 Nov 2022
Last updated: 9 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis

All Invasive Candidiasis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Clinical Trial to Evaluate the Safety, Efficacy and Population Pharmacokinetics of Amphotericin B Cholesteryl Sulfate Complex for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus
ClinicalTrials.gov ID: NCT05707832
Acronym / sponsor ID: HF114-006
Conditions: Invasive Candidiasis, Invasive Aspergillosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Mar 2023 (actual)
Primary completion: 30 Jul 2024 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 1 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Amphotericin B cholesteryl Sulfate Complex for Injection	Experimental	Drug: Amphotericin B cholesteryl Sulfate Complex for InjectionSubjects will receive ABCD intravenous injection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;
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;

Key exclusion criteria (24 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amphotericin B cholesteryl Sulfate Complex for InjectionIntravenous injection (IV), once a day after reaching the recommended dose of 3.0-4.0 mg/kg for treatment. Subjects will receive ABCD intravenous therapy for at least 2 weeks, and the longest course of treatment will not exceed 6 weeks.	Drug	Amphotericin B cholesteryl Sulfate Complex for Injection

Primary outcome

The number and percentage of subjects whose treatment is terminated due to study abnormal laboratory tests leads to drug related adverse events.
Time frame: From Day 1 to the end of treatment, no more than 6 weeks.
The number and percentage of subjects whose treatment is terminated due to study abnormal laboratory tests leads to drug related adverse events.
The number and percentage of subjects whose treatment is terminated due to study the infusion reaction leads to drug related adverse events.
Time frame: From Day 1 to the end of treatment, no more than 6 weeks.
The number and percentage of subjects whose treatment is terminated due to study the infusion reaction leads to drug related adverse events.
The number and percentage of subjects with study the infusion reaction leads to drug related adverse events.
Time frame: From Day 1 to the end of treatment, no more than 8 weeks.
The number and percentage of subjects with study the infusion reaction leads to drug related adverse events.
The number and percentage of subjects with study abnormal laboratory tests leads to drug related adverse events.
Time frame: From Day 1 to the end of treatment, no more than 8 weeks.
The number and percentage of subjects with study abnormal laboratory tests leads to drug related adverse events.

5 secondary outcomes

Population pharmacokinetic characteristics (PPK analysis)
Time frame: From Day 1 to the end of treatment, no more than 8 weeks.
The proportion of subjects who are generally effective
Time frame: From Day 1 to the end of treatment, no more than 44 days.
Percentage of subjects that are microbiologically valid
Time frame: From Day 1 to the end of treatment, no more than 8 weeks.
The proportion of subjects who are generally effective at the end of treatment and relapse at the end of treatment
Time frame: From Day 1 to the end of treatment, no more than 8 weeks.
All-cause mortality at 30 days after initiation of ABCD
Time frame: From Day 1 to Day 30.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Individual participant dataSharing planned: No

Related trials for Invasive Candidiasis

RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sizhou Feng principal investigator

Chinese Academy of Medical Sciences

Mei Hong principal investigator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Ming H principal investigator

Qilu Hospital of Shandong University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and percentage of subjects whose treatment is terminated due to study abnormal laboratory tests leads to drug related adverse events. (time frame: From Day 1 to the end of treatment, no more than 6 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05707832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.