An observational study in Fungal Infection, Aspergillosis and Mucormycosis, sponsored by Shanghai 10th People's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Shanghai 10th People's Hospital · Observational
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:
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's planned enrollment of 75 is below the median of 153 across 85 observational studies indexed under Mycoses.
Browse Mycoses studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult ICU patients meeting criteria for isavuconazole therapy according to the '2023 Isavuconazole Clinical Expert Consensus'
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: Isavuconazole treatment
Administer isavuconazole as follows: Loading dose: 200 mg every 8 hours (q8h) for three times, Maintenance dose: 200 mg once daily (qd)
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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: Enrollment (Baseline) → Treatment Day 42
Electrocardiogram QT Interval
A 6-lead ECG was performed.
Time frame: 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)
Time frame: From enrollment (Day 0) through Treatment Day 42
No study locations are listed for this record.
Plan to share: Yes — Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: Data will be made available through Corresponding author's email upon reasonable request to the corresponding author, subject to privacy/ethical restrictions
No publications or documents are linked to this record.
Start is estimated for Aug 2025; primary completion for Dec 2029, 52 months later.
Of 28 observational studies under Mycoses, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17. This study's planned 52 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai 10th People's Hospital →