EfficacyNCT06123832
Study of the Clinical Benefits of Different Formulations of Amphotericin B
An observational study of Efficacy and Safety, run by Qianfoshan Hospital at 1 site in China.
Trial summary
This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug… Read more about this study
- Who is it for?
- Any age
- Type of treatment
- Injection or infusion
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with documented amphotericin B use discharged from 5 tertiary care hospitals across the country from January 1, 2020 to the present were selected for the study to exclude patients with missing key information for the study and were divided into experimental and control groups for the study.
Who may be able to join
- Patients discharged from January 1, 2020 to the present;
- Patients with a record of amphotericin B use.
Who cannot join
- 1.Key information missing from patient studies.
Trial locations and contacts
1 site in 1 country.
About this study
This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.
Read the detailed description
The researchers selected patients with amphotericin B use records discharged from five tertiary hospitals across the country from January 1, 2020 to the present, extracted data according to the inclusion and exclusion criteria, and divided them into experimental and control groups, in order to understand the current status of amphotericin B use in each preparation type, compare the differences in the safety and efficacy of the various preparations in the domestic clinical application, and provide real-world evidence of the choice of clinical medication.
- Keywords
- Liposomal Amphotericin B for Injection, Amphotericin B Cholesteryl Sulfate Complex for Injection, Amphotericin B for Injection, Safety, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Liposomal Amphotericin B for Injection (Ampicillin®) | |
| Control Group | Liposome of Amphotericin B for Injection (Fungoxone®), Cholesteryl Sulfate Complex of Amphotericin B for Injection (Amphotericin®), Amphotericin B for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Adverse Reaction Rate
The incidence of total adverse reactions was analyzed to assess the difference in safety of amphotericin B by formulation type in domestic clinical application, to provide real-world evidence for clinical drug selection, and to provide evidence-based evidence in support of rational clinical drug use.
Measured: Through study completion,up to half a year.
Pathogen clearance rate
To assess the differences in effectiveness of amphotericin B by formulation type in domestic clinical application by analyzing the pathogen clearance rate, to provide real-world evidence for clinical dosing selection, and to provide evidence-based evidence to support rational clinical dosing.
Measured: Through study completion,up to half a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Yang, Qianfoshan Hospital
- Investigators
- Rui Yang, MD, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123832
- Sponsor's protocol ID
- LCYX-YR-20230102
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 17 Oct 2024
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical Benefits of Different Formulations of Amphotericin B
- ClinicalTrials.gov ID
- NCT06123832
- Acronym / sponsor ID
- LCYX-YR-20230102
- Keywords
- Liposomal Amphotericin B for Injection, Amphotericin B Cholesteryl Sulfate Complex for Injection, Amphotericin B for Injection, Safety, Efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Nov 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.
This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.
Detailed description
The researchers selected patients with amphotericin B use records discharged from five tertiary hospitals across the country from January 1, 2020 to the present, extracted data according to the inclusion and exclusion criteria, and divided them into experimental and control groups, in order to understand the current status of amphotericin B use in each preparation type, compare the differences in the safety and efficacy of the various preparations in the domestic clinical application, and provide real-world evidence of the choice of clinical medication.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –Liposomal Amphotericin B for Injection (Ampicillin®) |
| Control Group | – | –Liposome of Amphotericin B for Injection (Fungoxone®), Cholesteryl Sulfate Complex of Amphotericin B for Injection (Amphotericin®), Amphotericin B for Injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with documented amphotericin B use discharged from 5 tertiary care hospitals across the country from January 1, 2020 to the present were selected for the study to exclude patients with missing key information for the study and were divided into experimental and control groups for the study.
Key inclusion criteria (2 listed)
- Patients discharged from January 1, 2020 to the present;
- Patients with a record of amphotericin B use.
Key exclusion criteria (1 listed)
- 1.Key information missing from patient studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Adverse Reaction Rate
Time frame: Through study completion,up to half a year.
The incidence of total adverse reactions was analyzed to assess the difference in safety of amphotericin B by formulation type in domestic clinical application, to provide real-world evidence for clinical drug selection, and to provide evidence-based evidence in support of rational clinical drug use.
Pathogen clearance rate
Time frame: Through study completion,up to half a year.
To assess the differences in effectiveness of amphotericin B by formulation type in domestic clinical application by analyzing the pathogen clearance rate, to provide real-world evidence for clinical dosing selection, and to provide evidence-based evidence to support rational clinical dosing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- 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.
Rui Yang, MD principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy and Safety, run by Qianfoshan Hospital at 1 site in China.
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 2 inclusion and 1 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 17 Oct 2024. 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.
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?
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?
Overall Adverse Reaction Rate (time frame: Through study completion,up to half a year.). The study lists 2 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 17 Oct 2024.