Invasive Fungal InfectionsTRIM-1NCT07716878
Isavuconazole Therapeutic Drug Monitoring in Transplant Recipients
An observational study of Invasive Fungal Infections and Lung Transplantation, run by Zhibin Xu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Fungal Infections, Lung Transplantation, Hematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- Isavuconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No available plasma isavuconazole trough concentration
- Incomplete key clinical or dosing records precluding analysis
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: Therapeutic Drug Monitoring of Isavuconazole in Solid Organ and Hematopoietic Stem Cell Transplant Recipients: A Single-Center Retrospective Cohort Study of Plasma Trough Exposure, Its Determinants, and Hepatic Safety
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.
Read the detailed description
This is a single-center, retrospective, observational cohort study conducted at the First Affiliated Hospital of Guangzhou Medical University. It includes solid organ transplant (lung, kidney, liver) and hematopoietic stem cell transplant recipients who received isavuconazole for the prophylaxis or treatment of invasive fungal infections between January 2024 and April 2026 and who had at least one plasma isavuconazole trough concentration measured by routine therapeutic drug monitoring (TDM).
The primary objective is to characterize the distribution and the within- and between-patient variability of isavuconazole plasma trough concentrations and to identify clinical and pharmacogenetic determinants of drug exposure. Secondary objectives include describing attainment of a pre-specified target trough window (1-7 µg/mL); the relationship between isavuconazole exposure and calcineurin-inhibitor (tacrolimus, cyclosporine) concentrations; and the association of isavuconazole exposure with hepatic function abnormalities and all-cause mortality.
Demographic, clinical, laboratory, immunosuppressant, CYP3A5 genotype, and TDM data are extracted from medical records. Trough concentrations are analyzed at both the measurement level and the patient level. Determinants of log-transformed trough concentration are evaluated using linear mixed-effects models with a patient-level random intercept to account for repeated measurements. Subgroup analyses are pre-specified by transplant type (lung, kidney, liver, hematopoietic stem cell), treatment scenario (prophylaxis vs treatment), age (adult vs pediatric), and CYP3A5 genotype, with case-series description for small subgroups; a sensitivity analysis restricted to adults is also performed. No study intervention is assigned; all data reflect routine clinical care. The study is reported in accordance with the STROBE statement and was approved by the institutional ethics committee (approval number ES-2025-K203-01).
- Conditions
- Invasive Fungal Infections, Lung Transplantation, Hematopoietic Stem Cell Transplantation (HSCT), Kidney Transplantation, Liver Transplantation (LT)
- Being tested
- Isavuconazole
- Keywords
- Isavuconazole, Therapeutic Drug Monitoring, Trough Concentration, Antifungal Triazole, Pharmacokinetics, CYP3A5, Drug Exposure Variability
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsavuconazoleDrug
Isavuconazole administered orally or intravenously as part of routine clinical care; plasma trough concentrations measured by routine therapeutic drug monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Treatment cohort | Transplant recipients who received isavuconazole for the treatment of suspected or documented invasive fungal infection. Receives: Drug: Isavuconazole | |
| Prophylaxis cohort | Transplant recipients who received isavuconazole for the prophylaxis of invasive fungal infection. Receives: Drug: Isavuconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the study period (January 2024 to April 2026)
Secondary outcomes (5)
Determinants of isavuconazole trough concentration
Clinical and pharmacogenetic factors independently associated with log-transformed trough concentration, estimated by linear mixed-effects models (e.g., weight-adjusted daily dose, serum albumin, total bilirubin, estimated glomerular filtration rate, hemoglobin, transplant type, CYP3A5 genotype).
Measured: During the study period (January 2024 to April 2026)
Attainment of the target trough window (1-7 µg/mL)
Proportion of trough measurements falling within the pre-specified target window of 1-7 µg/mL, and below (<1 µg/mL) or above (>7 µg/mL) it.
Measured: During the study period (January 2024 to April 2026)
Association between isavuconazole exposure and hepatic function abnormality
Association between isavuconazole trough concentration and hepatic function abnormality, defined as alanine or aspartate aminotransferase >120 U/L and/or total bilirubin >21 µmol/L.
Measured: During the study period (January 2024 to April 2026)
Correlation between isavuconazole and calcineurin-inhibitor concentrations
Spearman correlation between concurrently measured isavuconazole trough concentrations and tacrolimus or cyclosporine blood concentrations.
Measured: During the study period (January 2024 to April 2026)
All-cause mortality
All-cause mortality during follow-up and its association with isavuconazole exposure.
Measured: During the study period (January 2024 to April 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jan 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhibin Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhibin Xu, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716878
- Sponsor's protocol ID
- ES-2025-K203-01
- Acronym
- TRIM-1
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Isavuconazole in Solid Organ and Hematopoietic Stem Cell Transplant Recipients: A Single-Center Retrospective Cohort Study of Plasma Trough Exposure, Its Determinants, and Hepatic Safety
- ClinicalTrials.gov ID
- NCT07716878
- Acronym / sponsor ID
- TRIM-1 / ES-2025-K203-01
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Zhibin XuUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, retrospective, observational cohort study conducted at the First Affiliated Hospital of Guangzhou Medical University. It includes solid organ transplant (lung, kidney, liver) and hematopoietic stem cell transplant recipients who received isavuconazole for the prophylaxis or treatment of invasive fungal infections between January 2024 and April 2026 and who had at least one plasma isavuconazole trough concentration measured by routine therapeutic drug monitoring (TDM).
The primary objective is to characterize the distribution and the within- and between-patient variability of isavuconazole plasma trough concentrations and to identify clinical and pharmacogenetic determinants of drug exposure. Secondary objectives include describing attainment of a pre-specified target trough window (1-7 µg/mL); the relationship between isavuconazole exposure and calcineurin-inhibitor (tacrolimus, cyclosporine) concentrations; and the association of isavuconazole exposure with hepatic function abnormalities and all-cause mortality.
Demographic, clinical, laboratory, immunosuppressant, CYP3A5 genotype, and TDM data are extracted from medical records. Trough concentrations are analyzed at both the measurement level and the patient level. Determinants of log-transformed trough concentration are evaluated using linear mixed-effects models with a patient-level random intercept to account for repeated measurements. Subgroup analyses are pre-specified by transplant type (lung, kidney, liver, hematopoietic stem cell), treatment scenario (prophylaxis vs treatment), age (adult vs pediatric), and CYP3A5 genotype, with case-series description for small subgroups; a sensitivity analysis restricted to adults is also performed. No study intervention is assigned; all data reflect routine clinical care. The study is reported in accordance with the STROBE statement and was approved by the institutional ethics committee (approval number ES-2025-K203-01).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment cohort | – | Drug: IsavuconazoleTransplant recipients who received isavuconazole for the treatment of suspected or documented invasive fungal infection. |
| Prophylaxis cohort | – | Drug: IsavuconazoleTransplant recipients who received isavuconazole for the prophylaxis of invasive fungal infection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- No available plasma isavuconazole trough concentration
- Incomplete key clinical or dosing records precluding analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsavuconazoleIsavuconazole administered orally or intravenously as part of routine clinical care; plasma trough concentrations measured by routine therapeutic drug monitoring. | Drug | Prophylaxis cohort, Treatment cohort |
Primary outcome
Plasma isavuconazole trough concentration
Time frame: During the study period (January 2024 to April 2026)
Distribution (median [IQR], range) and within- and between-patient variability (coefficient of variation) of plasma isavuconazole trough concentrations obtained by routine therapeutic drug monitoring.
5 secondary outcomes
Determinants of isavuconazole trough concentration
Time frame: During the study period (January 2024 to April 2026)
Attainment of the target trough window (1-7 µg/mL)
Time frame: During the study period (January 2024 to April 2026)
Association between isavuconazole exposure and hepatic function abnormality
Time frame: During the study period (January 2024 to April 2026)
Correlation between isavuconazole and calcineurin-inhibitor concentrations
Time frame: During the study period (January 2024 to April 2026)
All-cause mortality
Time frame: During the study period (January 2024 to April 2026)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections and Lung Transplantation, run by Zhibin Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma isavuconazole trough concentration (time frame: During the study period (January 2024 to April 2026)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.