Isavuconazole Therapeutic Drug Monitoring in Transplant Recipients

NCT07716878 | Completed

• 1 other identifier: ES-2025-K203-01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Isavuconazole is an antifungal medicine used to prevent or treat serious fungal infections in people who have received a solid organ transplant (mainly lung, and also kidney or liver) or a hematopoietic stem cell (bone marrow) transplant. Because these patients take medicines that suppress the immune system, they are at high risk of fungal infections. The amount of isavuconazole in the blood can vary widely from person to person, and it is not fully understood what drives these differences or whether higher blood levels are linked to side effects such as liver problems.This study reviews the medical records of transplant recipients who were treated with isavuconazole at a single hospital in China between January 2024 and April 2026. Using results from routine therapeutic drug monitoring (blood tests that measure the drug level), the researchers describe how isavuconazole blood levels are distributed, how much they vary within and between patients, and which clinical and genetic factors are associated with higher or lower levels. The study also examines whether isavuconazole blood levels are related to liver function abnormalities and to survival. Because this is an observational study, no treatment was assigned for research purposes; the study only analyzes data collected during routine clinical care. The findings are intended to help guide individualized dosing and monitoring of isavuconazole in transplant recipients.

Conditions

Invasive Fungal Infections; Lung Transplantation; Hematopoietic Stem Cell Transplantation (HSCT); Kidney Transplantation; Liver Transplantation (LT)

Keywords

Isavuconazole; Therapeutic Drug Monitoring; Trough Concentration; Antifungal Triazole; Pharmacokinetics; CYP3A5; Drug Exposure Variability

Outcome Measures

Primary Outcomes (1)

• Plasma isavuconazole trough concentration

  Distribution (median \[IQR\], range) and within- and between-patient variability (coefficient of variation) of plasma isavuconazole trough concentrations obtained by routine therapeutic drug monitoring.

  During the study period (January 2024 to April 2026)

Secondary Outcomes (5)

• Determinants of isavuconazole trough concentration

  During the study period (January 2024 to April 2026)

• Attainment of the target trough window (1-7 µg/mL)

  During the study period (January 2024 to April 2026)

• Association between isavuconazole exposure and hepatic function abnormality

  During the study period (January 2024 to April 2026)

• Correlation between isavuconazole and calcineurin-inhibitor concentrations

  During the study period (January 2024 to April 2026)

• All-cause mortality

  During the study period (January 2024 to April 2026)

Study Arms (2)

Treatment cohort

Transplant recipients who received isavuconazole for the treatment of suspected or documented invasive fungal infection.

Drug: Isavuconazole

Prophylaxis cohort

Transplant recipients who received isavuconazole for the prophylaxis of invasive fungal infection.

Drug: Isavuconazole

Interventions

Isavuconazole DRUG

Isavuconazole administered orally or intravenously as part of routine clinical care; plasma trough concentrations measured by routine therapeutic drug monitoring.

Prophylaxis cohort; Treatment cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive solid organ (lung, kidney, liver) and hematopoietic stem cell transplant recipients who received isavuconazole and underwent routine therapeutic drug monitoring at a single tertiary-care hospital in China between January 2024 and April 2026. A total of 110 recipients were included (89 lung, 6 kidney, 2 liver, and 13 hematopoietic stem cell transplant), contributing 427 trough concentration measurements.

You may qualify if:

• Recipients of solid organ transplantation (lung, kidney, or liver) or hematopoietic stem cell transplantation
• Received isavuconazole for prophylaxis or treatment of invasive fungal infection during the study period, with traceable prescription and administration records
• Isavuconazole treatment duration of at least 7 days and at least one measured plasma isavuconazole trough concentration
• Adequate follow-up information to assess the main study variables

You may not qualify if:

• No available plasma isavuconazole trough concentration
• Incomplete key clinical or dosing records precluding analysis

Sponsors & Collaborators

• Zhibin Xu: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

isavuconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: January 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)