An interventional study of Theraputic drug monitoring and Isavuconazole in Aspergillosis Invasive and Mucormycosis, sponsored by Shanghai Children's Medical Center. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Shanghai Children's Medical Center · Not applicable, Interventional, and Treatment
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.
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.
32 studies on the registry are indexed under Mucormycosis; 8 are open to participants now.
This study's planned enrollment of 200 is above the median of 82 across 13 interventional studies indexed under Mucormycosis.
Browse Mucormycosis studies →Shanghai Children's Medical Center is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Theraputic drug monitoring
Other: Theraputic drug monitoring · Drug: Isavuconazole
High Performance Liquid Chromatography (HPLC) is used to determine the plasma concentrations of isavuconazole
Isavuconazole
Plasma concentrations of isavuconazole
High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole
Time frame: 30 minutes before next dosing
Treatment success rates for IMI
Percentage of patients who were assessed by the study physician as clinically cured and improved
Time frame: 6 months
AE and SAE
Number and percentage of AE and SAE
Time frame: 6 months
Plan to share: Yes — Date of sharing: after publication of the study results; Way of sharing: Contact the investigator for request
Supporting information: Study protocol, Clinical study report
Time frame: After publication of the study results
Access criteria: Contact the investigator for request
No publications or documents are linked to this record.
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Studies of the drug tested here: Isavuconazole
Shanghai Children's Medical Center