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NCT Number: NCT07496008

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.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.

Exclusion criteria

  • 1.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.

Treatment and study plan

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).

Primary outcomes

  1. Isavuconazole plasma concentration

    Time frame: after 3 days of antibiotic therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Yaping Yuan Clinical Professor

CONTACT

[email protected]

010-876250

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.