Invasive CandidiasisPhase 2NCT04225195
Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis
A Phase 2 study testing Amphotericin B cholesteryl sulfate complex for injection(ABCD) in people with Invasive Candidiasis and Invasive Aspergillosis, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial summary
This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Invasive Candidiasis, Invasive Aspergillosis
- What is being tested?
- Amphotericin B cholesteryl sulfate complex for injection(ABCD)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Jun 2022
- Phase
- Phase 2
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
- Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
- Female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment.
- Signed Informed Consent Form.
Who cannot join
- Allergic to ABCD or azole antifungal drugs；
- For IC patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin B in 7 days;
- For IA patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin B in 7 days;
- Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
- Patients with a history of drug abuse or drug dependence;
- Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis;
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- Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective;
- Patients with abnormal liver function;
- Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis;
- Hypokalemia, which cannot be corrected before trial treatment;
- Expected survival time is less than 2 months;
- Patients with cardiac function of New York Heart Association（NYHA）class III/IV;
- Positive for HIV antibody;
- Pregnant or lactating women;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetics of ABCD for Invasive Candidiasis and Invasive Aspergillosis
This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.
Read the detailed description
This study will evaluate the safety, efficacy and population pharmacokinetic characteristics of ABCD in the treatment of invasive candidiasis and invasive aspergillosis. About 60 patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis will be enrolled.
- Conditions
- Invasive Candidiasis, Invasive Aspergillosis
- Being tested
- Amphotericin B cholesteryl sulfate complex for injection(ABCD)
- 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 injection(ABCD)Drug
Also called ABCD
IC patients will only receive intravenous treatment with ABCD, with the longest course of treatment up to 42 days. ABCD will be administered once a day at a dose of 3-4 mg/kg. Visit plan: screening period (D-4 to D-1), baseline period (D1), treatment period and follow-up period (14±3days after the end of the last dose of ABCD).
IA patients will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. The total course of treatment should be at least 6 to 12 weeks. ABCD dosing regimen will be the same as that for IC patients. Visiting plan: screening period (D-4to D-1), baseline period (D1), treatment period and follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B cholesteryl sulfate complex for injection(ABCD) | Experimental | Patients with invasive candidiasis (IC) will only receive intravenous treatment with ABCD. ABCD will be administered once a day at a dose of 3-4 mg/kg.
Patients with invasive aspergillosis (IA) will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. ABCD dosing regimen will be the same as that for IC patients. Receives: Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Measured: 4-6 weeks
Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set
Overall response success rate at the end of ABCD treatment, m ITT analysis set
Measured: 4-6 weeks
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Measured: 4-6 weeks
Secondary outcomes (3)
Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.
Overall response success rate at the end of ABCD treatment, PPS analysis set.
Measured: 4-6 weeks
The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set
The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set
Measured: 4-6 weeks
30-d all-cause mortality rate after starting treatment; mITT analysis set
30-d all-cause mortality rate after starting treatment; mITT analysis set
Measured: 30 days after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJun 2022 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- mingui wang, Principal investigator, Huashan Hospital affiliated to Fudan University ,Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225195
- Sponsor's protocol ID
- CSPC/ LXMSB201901/PRO-III/A
- Status last verified
- Dec 2019
- First submitted
- 3 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetics of ABCD for Invasive Candidiasis and Invasive Aspergillosis
- ClinicalTrials.gov ID
- NCT04225195
- Acronym / sponsor ID
- CSPC/ LXMSB201901/PRO-III/A
- Conditions
- Invasive Candidiasis, Invasive Aspergillosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 13 Jan 2020 (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.
This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.
Detailed description
This study will evaluate the safety, efficacy and population pharmacokinetic characteristics of ABCD in the treatment of invasive candidiasis and invasive aspergillosis. About 60 patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis will be enrolled.
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(ABCD) | Experimental | Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD)Patients with invasive candidiasis (IC) will only receive intravenous treatment with ABCD. ABCD will be administered once a day at a dose of 3-4 mg/kg. Patients with invasive aspergillosis (IA) will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. ABCD dosing regimen will be the same as that for IC patients. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
- Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
- Female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment.
- Signed Informed Consent Form.
Key exclusion criteria (14 listed)
- Allergic to ABCD or azole antifungal drugs；
- For IC patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin B in 7 days;
- For IA patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin B in 7 days;
- Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
- Patients with a history of drug abuse or drug dependence;
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 injection(ABCD)Also: ABCDIC patients will only receive intravenous treatment with ABCD, with the longest course of treatment up to 42 days. ABCD will be administered once a day at a dose of 3-4 mg/kg. Visit plan: screening period (D-4 to D-1), baseline period (D1), treatment period and follow-up period (14±3days after the end of the last dose of ABCD). IA patients will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. The total course of treatment should be at least 6 to 12 weeks. ABCD dosing regimen will be the same as that for IC patients. Visiting plan: screening period (D-4to D-1), baseline period (D1), treatment period and follow-up period. | Drug | Amphotericin B cholesteryl sulfate complex for injection(ABCD) |
Primary outcome
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set
Time frame: 4-6 weeks
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set
Time frame: 4-6 weeks
Overall response success rate at the end of ABCD treatment, m ITT analysis set
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Time frame: 4-6 weeks
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
3 secondary outcomes
Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.
Time frame: 4-6 weeks
The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set
Time frame: 4-6 weeks
30-d all-cause mortality rate after starting treatment; mITT analysis set
Time frame: 30 days after starting treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
mingui wang principal investigator
Huashan Hospital affiliated to Fudan University ,Shanghai, China
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amphotericin B cholesteryl sulfate complex for injection(ABCD) in people with Invasive Candidiasis and Invasive Aspergillosis, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiugao yang (86-021-60677906, yangxiugao@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set (time frame: 4-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.