Fungal InfectionNCT07080359
Isavuconazole in Critically Ill Patients: Efficacy and Safety
An observational study of Fungal Infection and Aspergillosis, run by Shanghai 10th People's Hospital.
Trial summary
Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in healthy individuals, exhibiting significant variability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection, Aspergillosis, Mucormycosis
- What is being tested?
- Isavuconazole treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2030
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'
Who may be able to join
- Adult critically ill patients (≥18 years) admitted to ICU with suspected or confirmed invasive fungal infection (IFI)
- IFI diagnosis per EORTC/MSGERC 2019 criteria
Who cannot join
- Drug allergy
- Inherited short QT syndrome
- Contraindications for nasogastric/oral drug delivery
- <18 years old
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
Official title: Isavuconazole in Critically Ill Patients: A Study on Antifungal Efficacy and Safety
Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in healthy individuals, exhibiting significant variability.
This study aims to explore the variability of isavuconazole plasma concentrations in critically ill patients and its correlation with efficacy and adverse effects. The research includes:
- The distribution and variability of isavuconazole plasma concentrations in critically ill patients;
- Clinical outcomes;
- Adverse effects.
- Conditions
- Fungal Infection, Aspergillosis, Mucormycosis
- Being tested
- Isavuconazole treatment
- Medical subject headings
- Mycoses, Aspergillosis, Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isavuconazole treatmentDrug
Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)
| Study group | Role | What they receive |
|---|---|---|
| Isavuconazole group | Critically ill patients who meet the indicated conditions per the prescribing information, administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd) Receives: Drug: Isavuconazole treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological Progress in Pulmonary Fungal Infections
A chest CT uses X-ray tomography, where the patient lies on a table while the machine rotates to capture cross-sectional images
Measured: At treatment day 42
Plasma concentration
Venous blood samples were collected, centrifuged to obtain supernatant, and concentrations were measured by liquid chromatography-tandem mass spectrometry
Measured: On or after day 7 post-dose
Change in immune function profiles (cellular and humoral immunity markers)
Specific immune markers (e.g., CD4+/CD8+ counts, immunoglobulin levels, or cytokine profiles) will be selected based on emerging evidence or preliminary data prior to finalizing the statistical analysis plan.
Measured: Enrollment (Baseline) → Treatment Day 42
Composite infection biomarker profile (including PCT, CRP, IL-6 and WBC)
The assessment of infection progression is conducted through a comprehensive scoring system as follows:
Infection Biomarker Score (0-8 points) based on:
- PCT >0.5 ng/mL (2 point)
- CRP >10 mg/L (1 point)
- IL-6 >30 pg/mL (2 point)
- WBC >10×10⁹/L (3 point)
Measured: Enrollment (Baseline) → Treatment Day 42
Secondary outcomes (2)
Electrocardiogram QT Interval
A 6-lead ECG was performed.
Measured: On day 10 post-dose
Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin).
Hepatic function will be assessed using a composite scoring system (0-10 points) incorporating:
ALT elevation >3×ULN (2 points) AST elevation >3×ULN (2 points) Total bilirubin >2×ULN (3 points)
- ALP >2×ULN (2 points)
- Albumin <3.0 g/dL (1 point)
Measured: From enrollment (Day 0) through Treatment Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies 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
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Xiang Cao, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080359
- Sponsor's protocol ID
- SHSY-IEC-6.0/25K114/P01
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isavuconazole in Critically Ill Patients: A Study on Antifungal Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07080359
- Acronym / sponsor ID
- SHSY-IEC-6.0/25K114/P01
- Conditions
- Fungal Infection, Aspergillosis, Mucormycosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Jul 2025 (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.
Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in healthy individuals, exhibiting significant variability.
This study aims to explore the variability of isavuconazole plasma concentrations in critically ill patients and its correlation with efficacy and adverse effects. The research includes:
- The distribution and variability of isavuconazole plasma concentrations in critically ill patients;
- Clinical outcomes;
- Adverse effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Isavuconazole group | – | Drug: Isavuconazole treatmentCritically ill patients who meet the indicated conditions per the prescribing information, administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'
Key inclusion criteria (2 listed)
- Adult critically ill patients (≥18 years) admitted to ICU with suspected or confirmed invasive fungal infection (IFI)
- IFI diagnosis per EORTC/MSGERC 2019 criteria
Key exclusion criteria (4 listed)
- Drug allergy
- Inherited short QT syndrome
- Contraindications for nasogastric/oral drug delivery
- <18 years old
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 |
|---|---|---|
| Isavuconazole treatmentAdminister isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd) | Drug | Isavuconazole group |
Primary outcome
Radiological Progress in Pulmonary Fungal Infections
Time frame: At treatment day 42
A chest CT uses X-ray tomography, where the patient lies on a table while the machine rotates to capture cross-sectional images
Plasma concentration
Time frame: On or after day 7 post-dose
Venous blood samples were collected, centrifuged to obtain supernatant, and concentrations were measured by liquid chromatography-tandem mass spectrometry
Change in immune function profiles (cellular and humoral immunity markers)
Time frame: Enrollment (Baseline) → Treatment Day 42
Specific immune markers (e.g., CD4+/CD8+ counts, immunoglobulin levels, or cytokine profiles) will be selected based on emerging evidence or preliminary data prior to finalizing the statistical analysis plan.
Composite infection biomarker profile (including PCT, CRP, IL-6 and WBC)
Time frame: Enrollment (Baseline) → Treatment Day 42
The assessment of infection progression is conducted through a comprehensive scoring system as follows: Infection Biomarker Score (0-8 points) based on: * PCT >0.5 ng/mL (2 point) * CRP >10 mg/L (1 point) * IL-6 >30 pg/mL (2 point) * WBC >10×10⁹/L (3 point)
2 secondary outcomes
Electrocardiogram QT Interval
Time frame: On day 10 post-dose
Composite liver function outcome (including ALT, AST, bilirubin, ALP, and albumin).
Time frame: From enrollment (Day 0) through Treatment Day 42
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 23 Jul 2025.
- Individual participant dataSharing planned: Yes. Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
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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 Fungal Infection and Aspergillosis, run by Shanghai 10th People's 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 2 inclusion and 4 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 23 Jul 2025. 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 Wen-Xiang Cao (+8613062772669, 731438603@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological Progress in Pulmonary Fungal Infections (time frame: At treatment day 42). The study lists 4 primary outcomes in all. 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 23 Jul 2025.