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

NCT07496008 | Not Yet Recruiting DMC

• 1 other identifier: S2025-448-03
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

invasion pulmonary mycosis; Isavuconazole

Outcome Measures

Primary Outcomes (1)

• Isavuconazole plasma concentration

  after 3 days of antibiotic therapy

Study Arms (1)

isavuconazole

Clinical Blood Sampling Protocol for isavuconazole in Geriatric Patients: Elderly patients received isavuconazole. After 5-7 days of antibiotic therapy (steady-state achievement), blood sampling was performed as follows: Trough Concentration: A 3-mL peripheral blood sample was collected from the antecubital vein pre-dose (before the next scheduled administration) using EDTA-containing Vacutainers®. Peak Concentration: A blood sample was drawn immediately after completion of the intravenous infusion. All blood specimens were centrifuged at 2500 × g for 10 minutes. Plasma samples were stored at -20°C and analyzed within 1 week of collection via liquid chromatography-tandem mass spectrometry (LC-MS/MS).

Diagnostic Test: Liquid chromatography-tandem mass spectrometry

Interventions

Liquid chromatography-tandem mass spectrometry DIAGNOSTIC_TEST

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).

isavuconazole

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enroll patients aged ≥60 years receiving isavuconazole therapy at Chinese PLA General Hospital

You may qualify if:

• Aged over 60 years, with no restriction on gender; 2.Diagnosed with invasive aspergillosis and mucormycosis; 3.Receiving isavuconazole treatment (including loading dose and maintenance dose), with an anticipated treatment duration of ≥ 48 hours; 4.Clinically stable and able to undergo blood sample collection; 5.Having consented to participate in the study and voluntarily signed the informed consent form.

You may not qualify if:

• Allergy to any component of isavuconazole; 2.Pregnant women, breastfeeding women, or patients planning to become pregnant in the near future; 3.Inability to collect an adequate blood sample due to the patient's condition or technical reasons; 4.Patients deemed unsuitable for participation in the study by the investigator.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Central Study Contacts

Yaping Yuan Clinical Professor

CONTACT

010-876250; yuanyp301@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share