NCT07496008

Individualized Precision Isavuconazole Therapy Guided by PK/PD Principles for the Geriatric Population

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: —

Summary

Esconazole, as a novel triazole antifungal drug, has broad-spectrum antifungal activity, good tissue penetration and low toxicity risk. It has been recommended by domestic and international guidelines as a first-line treatment for invasive fungal infections. Due to its good pharmacokinetic properties and the lack of evidence to associate plasma concentration with efficacy and toxicity, therapeutic drug monitoring is not routinely recommended at present. However, the pharmacokinetic characteristics of isaconazole have not been fully clarified in special populations, especially elderly patients. Elderly patients often have multiple organ function declines (such as liver function damage and renal insufficiency), and need to use multiple drugs in combination for a long time. This may affect the activity of drug-metabolizing enzymes or the plasma protein binding rate to change their clearance ability, leading to further amplification of individual differences in blood drug concentrations. Based on this, this study intends to focus on elderly patients with invasive fungal infections and systematically explore the optimal administration regimen of esconazole. By systematically analyzing the current changes in blood drug concentration at different administration doses during treatment, as well as the related drug toxicity reactions and therapeutic effects, the independent influencing factors of dose adjustment were identified. The differences in efficacy and safety between individualized dose reduction regimens and standard regimens were compared to provide a basis for the precise treatment of isaconazole in elderly patients.

Conditions

• Isavuconazole
• Invasion Pulmonary Mycosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Liquid chromatography-tandem mass spectrometry	Blood samples were collected at different time points for drug concentration monitoring. Quantitative determination of isavuconazole concentrations in plasma was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Timeline

• Start date: 2026-03-25
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27