Aspergillosis InvasiveNCT06440915
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
A study testing Theraputic drug monitoring and Isavuconazole in people with Aspergillosis Invasive and Mucormycosis, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Aspergillosis Invasive, Mucormycosis
- What is being tested?
- Theraputic drug monitoring and Isavuconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who intend to take isavuconazole for the treatment of invasive mycosis;
- Aged 0-18 years, gender unlimited;
- The subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol;
- The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.
Who cannot join
- The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug;
- The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai
Juan Wu
About this study
The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are:
What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate.
Read more
Participants will:
Take drug isavuconazole as prescribed by the doctor;
1mL of blood is drawn 30min before the next dose.
Read the detailed description
Objectives of Study:
Main objective: To monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration.
Secondary objective: To evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients.
- Conditions
- Aspergillosis Invasive, Mucormycosis
- Being tested
- Theraputic drug monitoring, Isavuconazole
- Medical subject headings
- Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraputic drug monitoringOther
High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole
IsavuconazoleDrug
Isavuconazole
| Study group | Role | What they receive |
|---|---|---|
| Isavuconazole group | Other | Theraputic drug monitoring Receives: Other: Theraputic drug monitoring; Drug: Isavuconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of isavuconazole
High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole
Measured: 30 minutes before next dosing
Secondary outcomes (2)
Treatment success rates for IMI
Percentage of patients who were assessed by the study physician as clinically cured and improved
Measured: 6 months
AE and SAE
Number and percentage of AE and SAE
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start6 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspergillosis InvasiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Wu, PhD, Shanghai Children's Medical Center
- Investigators
- Juan Wu, PhD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440915
- Sponsor's protocol ID
- YJK-001
- Status last verified
- Dec 2024
- First submitted
- 20 May 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Date of sharing: after publication of the study results; Way of sharing: Contact the investigator for request
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
- ClinicalTrials.gov ID
- NCT06440915
- Acronym / sponsor ID
- YJK-001
- Conditions
- Aspergillosis Invasive, Mucormycosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 4 Jun 2024 (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.
The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are:
What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate.
Participants will:
Take drug isavuconazole as prescribed by the doctor;
1mL of blood is drawn 30min before the next dose.
Detailed description
Objectives of Study:
Main objective: To monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration.
Secondary objective: To evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isavuconazole group | Other | Other: Theraputic drug monitoring, Drug: IsavuconazoleTheraputic drug monitoring |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients who intend to take isavuconazole for the treatment of invasive mycosis;
- Aged 0-18 years, gender unlimited;
- The subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol;
- The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.
Key exclusion criteria (2 listed)
- The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug;
- The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.
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 |
|---|---|---|
| Theraputic drug monitoringHigh Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole | Other | Isavuconazole group |
| IsavuconazoleIsavuconazole | Drug | Isavuconazole group |
Primary outcome
Plasma concentrations of isavuconazole
Time frame: 30 minutes before next dosing
High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole
2 secondary outcomes
Treatment success rates for IMI
Time frame: 6 months
AE and SAE
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Yes. Date of sharing: after publication of the study results; Way of sharing: Contact the investigator for request
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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.
Juan Wu, PhD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theraputic drug monitoring and Isavuconazole in people with Aspergillosis Invasive and Mucormycosis, run by Shanghai Children's Medical Center 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Wu, PhD (+8618918397709, wujuan@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of isavuconazole (time frame: 30 minutes before next dosing). 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 Dec 2024.