Invasive Fungal InfectionsNCT05881109
Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents
An observational study of Invasive Fungal Infections, run by Shandong University at 1 site in China.
Trial summary
Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Caspogunfin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 3 Mar 2019
- 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 12 to 17 years
- All sexes
- Child
Study population: The adolescents (12 - 17 years old) undergoing allo-HSCT and receiving CAS as prevention or treatment for IFIs
Who may be able to join
- The adolescents (12 - 17 years) underwent allo-HSCT
- Use caspofungin for the prevention or treatment of fungal infections
Who cannot join
- Intolerable to caspofungin
- Participate into other clinical studies
- There are conditions that researchers do not consider it appropriate to join the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents With Allogeneic Hematopoietic Stem Cell Transplantation
Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to fungal infections. The study aimed to establish a population pharmacokinetic (PPK) model and assess the dosing schemes of CAS in adolescents with allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Conditions
- Invasive Fungal Infections
- Being tested
- Caspogunfin
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspogunfinDrug
No specific interventions were administrated. Participants receive interventions as part of routine medical care, where CAS was infused intravenously over 60 min at a loading dose of 70 mg/m2 on day 1, followed by a maintenance dose of 50 mg/m2 (maximum: 70 mg daily).
What is being measured
The primary outcome is the main question the study is designed to answer.
The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis
The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC90 (the lowest concentration of caspofungin at which 90% of the isolates were inhibited) (AUC24/MIC90) for C. albicans (0.06 mg/L), C. glabrata (450 mg/L), and C. parapsilosis (1185 mg/L) .
Measured: 1 day
The PTAs of AUC24/MIC for various species of Candida spp isolates
The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC (minimal inhibitory concentration) (AUC24/MIC) for various species of Candida spp isolates with a MIC range of 0.03 to 1.0 mg/L
Measured: 1 day
The PTAs of trough concentration
PTA of patients with CAS trough concentration ≥ 1 μg/mL
Measured: the trough concentration (24 hours after administration) at the steady state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Jan 2018
- Primary completion3 Mar 2019
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881109
- Sponsor's protocol ID
- caspofungin-001
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents With Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05881109
- Acronym / sponsor ID
- caspofungin-001
- Conditions
- Invasive Fungal Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 31 May 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.
Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to fungal infections. The study aimed to establish a population pharmacokinetic (PPK) model and assess the dosing schemes of CAS in adolescents with allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- The adolescents (12 - 17 years old) undergoing allo-HSCT and receiving CAS as prevention or treatment for IFIs
Key inclusion criteria (2 listed)
- The adolescents (12 - 17 years) underwent allo-HSCT
- Use caspofungin for the prevention or treatment of fungal infections
Key exclusion criteria (3 listed)
- Intolerable to caspofungin
- Participate into other clinical studies
- There are conditions that researchers do not consider it appropriate to join the research.
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 |
|---|---|---|
| CaspogunfinNo specific interventions were administrated. Participants receive interventions as part of routine medical care, where CAS was infused intravenously over 60 min at a loading dose of 70 mg/m2 on day 1, followed by a maintenance dose of 50 mg/m2 (maximum: 70 mg daily). | Drug | – |
Primary outcome
The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis
Time frame: 1 day
The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC90 (the lowest concentration of caspofungin at which 90% of the isolates were inhibited) (AUC24/MIC90) for C. albicans (0.06 mg/L), C. glabrata (450 mg/L), and C. parapsilosis (1185 mg/L) .
The PTAs of AUC24/MIC for various species of Candida spp isolates
Time frame: 1 day
The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC (minimal inhibitory concentration) (AUC24/MIC) for various species of Candida spp isolates with a MIC range of 0.03 to 1.0 mg/L
The PTAs of trough concentration
Time frame: the trough concentration (24 hours after administration) at the steady state
PTA of patients with CAS trough concentration ≥ 1 μg/mL
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 31 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Invasive Fungal Infections, run by Shandong University 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 3 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 31 May 2023. 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?
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 PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis (time frame: 1 day). 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 31 May 2023.