Study on Theraputic Drug Monitoring and Phamacokinetics o... | NCT06440915

Studies
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

NCT06440915

Sponsor

Shanghai Children's Medical Center

Status

Recruiting

Last Update Posted

Dec 13, 2024Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Aspergillosis Invasive
Mucormycosis

Interventions

Theraputic drug monitoring
Isavuconazole

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2024Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

May 20, 2024

First Submission Date that Met QC Criteria

Jun 1, 2024

First Posted Date

Jun 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2024

Last Update Posted Date

Dec 13, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan Wu, PhD, Principal Investigator, Shanghai Children's Medical CenterPrincipal Investigator

Lead Sponsor

Shanghai Children's Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isavuconazole group	Other	Theraputic drug monitoring	Other: Theraputic drug monitoring Drug: Isavuconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Theraputic drug monitoring	Other	High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole	Isavuconazole group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentrations of isavuconazole	High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole	30 minutes before next dosing

Secondary Outcomes

Measure	Description	Time Frame
Treatment success rates for IMI	Percentage of patients who were assessed by the study physician as clinically cured and improved	6 months
AE and SAE	Number and percentage of AE and SAE

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juan Wu, PhD	Contact	+8618918397709		wujuan@scmc.com.cn

Overall Officials

Name	Affiliation	Role
Juan Wu, PhD	Shanghai Children's Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Children's Medical Center	Recruiting	Shanghai			China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Date of sharing: after publication of the study results; Way of sharing: Contact the investigator for request

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

After publication of the study results

Access Criteria

Contact the investigator for request

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009091	Mucormycosis

Ancestor Terms

ID	Term
D020096	Zygomycosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C508735	isavuconazole

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided