IsavuconazoleNCT07496008
Individualized Precision Isavuconazole Therapy Guided by PK/PD Principles for the Geriatric Population
An observational study of Isavuconazole and Invasion Pulmonary Mycosis, run by Chinese PLA General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Isavuconazole, Invasion Pulmonary Mycosis
- What is being tested?
- Liquid chromatography-tandem mass spectrometry
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2026to 31 Dec 2029
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Adult, Older adult
Study population: Enroll patients aged ≥60 years receiving isavuconazole therapy at Chinese PLA General Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Liquid chromatography-tandem mass spectrometry
- Keywords
- invasion pulmonary mycosis, Isavuconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid chromatography-tandem mass spectrometryDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Liquid chromatography-tandem mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isavuconazole plasma concentration
Measured: after 3 days of antibiotic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start25 Mar 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsavuconazoleStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jionghe Wu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496008
- Sponsor's protocol ID
- S2025-448-03
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Precision Isavuconazole Therapy Guided by PK/PD Principles for the Geriatric Population
- ClinicalTrials.gov ID
- NCT07496008
- Acronym / sponsor ID
- S2025-448-03
- Conditions
- Isavuconazole, Invasion Pulmonary Mycosis
- Keywords
- invasion pulmonary mycosis, Isavuconazole
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| isavuconazole | – | Diagnostic Test: Liquid chromatography-tandem mass spectrometryClinical 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Enroll patients aged ≥60 years receiving isavuconazole therapy at Chinese PLA General Hospital
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Liquid chromatography-tandem mass spectrometryBlood 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). | Diagnostic test | isavuconazole |
Primary outcome
Isavuconazole plasma concentration
Time frame: after 3 days of antibiotic therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Isavuconazole and Invasion Pulmonary Mycosis, run by Chinese PLA General Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaping Yuan Clinical Professor (010-876250, yuanyp301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isavuconazole plasma concentration (time frame: after 3 days of antibiotic therapy). 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 27 Mar 2026.