A Phase 4 interventional study of SOC +Posaconazole 18 MG/ML (milligram/milliliter) and standard of care (SOC) in Aspergillosis; Pulmonary, Invasive (Etiology), sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Prevention
Among 12 studies in Aspergillosis with a site in Netherlands — 1 open to participants now, 1 under way, none of them phase 3. Aspergillosis · Netherlands.
Among the 12 studies in Aspergillosis with a site in Netherlands, this one is one of 4 that started in 2017, is the only one in phase 4, and was the 9th registered.
134 studies on the registry are indexed under Aspergillosis; 10 are open to participants now.
This study's enrollment of 88 is above the median of 47 across 75 interventional studies indexed under Aspergillosis.
Browse Aspergillosis studies →1 of the 12 studies in Aspergillosis with a site in Netherlands is open now, in 1 country. Each count lists the studies.
Of the 8 Aspergillosis studies recruiting now, 6 (75%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 4 started in 2017.
Median enrollment 135 across the 7 interventional studies, 203 across the 5 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
3 of 12 have an industry lead sponsor. The 9 most frequent:
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Universitaire Ziekenhuizen KU Leuven has 3 studies filed under Aspergillosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Aspergillosis with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
The objective of this study is to deliver proof of concept that antifungal prophylaxis can reduce the incidence of Influenza Associated Aspergillosis (IAA) in ICU (intensive care unit) patients with severe influenza.
The investigators will perform an interventional non-blinded randomized controlled multicentric proof-of-concept study in patients with severe influenza admitted to the ICU. Patients will be randomized to the posaconazole prophylaxis group or to the SOC (standard of care) group. Oseltamivir will be started at the discretion of the investigator. Patients in the posaconazole group will receive posaconazole prophylaxis for 7 days.
addendum: pharmacokinetics of posaconazole as prophylaxis for invasive fungal disease on ICU
Critically ill patients with PCR-confirmed influenza criteria) are eligible for inclusion in this study and will be randomized to or the posaconazole prophylaxis group or the SOC group.
If a patient is randomized to the posaconazole prophylaxis group, posaconazole (Noxafil, MSD) will be started intravenously from day 1 of randomization (2*300mg( milligram) /d on day 1, followed by 1*300mg/d from day 2 for 7 days) In both patient groups (prophylaxis and SOC) oseltamivir (non-IMP) will be started at the discretion of the treating physician from the first day of ICU admission as 2*150 mg/day for 10 days. If oseltamivir had already been started up before ICU admission, oseltamivir treatment will be continued up to a total of 10 days.
Within 48 hours after influenza diagnosis a bronchoscopy with BAL (bronchoalveolar lavage) and a serum galactomannan will be performed as part of routine ICU care in this type of patients. If an IAA-infection is suspected based on the result of this BAL ((A) Aspergillus cultured from BAL, or (B) a galactomannan (GM)the patient will be withdrawn from the study and antifungal treatment will be started.
addendum: Extensive PK sampling (UZ Leuven and Radboud): full PK curve on day 2 and day 5 (predose, 1.5; 2,3,4,6,8,10,12,18,24 h post infusion).
on non PK days, until day 7, predose sample. PK in BAL fluid only in patients with mechanical ventilation and when medically indicated.
Limited PK sampling: on day 2 and day 5: 1.5-3h, 4-8 h;8-12h; 12-24h post dose. on non PK days: PK pre dose.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
standard of care (SOC) treatment for influenza pneumonia +posaconazole 2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days; vials containing 18mg posaconazole /mL, 300mg posaconazole/vial in total)
Drug: SOC +Posaconazole 18 MG/ML (milligram/milliliter) · Other: standard of care (SOC)
standard of care treatment for influenza pneumonia (at the investigators discretion)
Other: standard of care (SOC)
Drug page: Posaconazole
.2\*300mg/d IV on day 1, followed by 1\*300mg/d IV from day 2 for 7 days (total 7 days)
Also known as: Noxafil
treatment for influenza pneumonia at the investigators discretion
Number of Participants With IAA-infection at ICU Discharge
A patient with IAA-infection is defined as a patient having mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities
Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
Time to IAPA Diagnosis
Days to influenza-associated pulmonary aspergillosis (IAPA) diagnosis
Time frame: from date of inclusion to date of first sign/symptom of IAA infection, assessed up to ICU discharge, approximately 10 days
Length of ICU Stay
amount of days at ICU
Time frame: from date of admission in ICU to date of discharge from ICU, approximately 20 days
Length of Hospital Stay
Number of days in the hospital
Time frame: from date of admission in hospital to date of discharge from hospital, approximately 25 days
ICU Mortality - Number of Participant Deaths
survival status
Time frame: At ICU discharge
Hospital Mortality - Number of Participant Deaths
Survival status at hospital discharge
Time frame: At hospital discharge
90-day Mortality - Number of Participant Deaths
Survival status at 90 days after ICU admission
Time frame: At 90 days after ICU admission
| Milestone | SOC + 'Posaconazole 18 Milligram/Milliliter' | Standard of Care |
|---|---|---|
| Started | 43 | 45 |
| Completed | 37 | 36 |
| Not completed | 6 | 9 |
A patient with IAA-infection is defined as a patient having mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities
| Participants | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| Number of Participants With IAA-infection at ICU Discharge | 2 | 4 |
Days to influenza-associated pulmonary aspergillosis (IAPA) diagnosis
| days | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| Time to IAPA Diagnosis | 10 (8 to 12) | 5 (3 to 8) |
amount of days at ICU
| days | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| Length of ICU Stay | 16 (8 to 29) | 6 (3 to 12) |
Number of days in the hospital
| days | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| Length of Hospital Stay | 25 (18 to 45) | 12 (9 to 35) |
survival status
| Participants | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| ICU Mortality - Number of Participant Deaths | 7 | 9 |
Survival status at hospital discharge
| Participants | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| Hospital Mortality - Number of Participant Deaths | 8 | 10 |
Survival status at 90 days after ICU admission
| Participants | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| 90-day Mortality - Number of Participant Deaths | 9 | 11 |
Collected over 90 days after ICU admission. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOC + 'Posaconazole 18 MG/ML' | 9/37 (24.3%) | 9/37 (24.3%) | — |
| Standard of Care | 11/36 (30.6%) | 11/36 (30.6%) | — |
| Event | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| DeathInfections and infestations | 9/37 | 11/36 |
| Event | SOC + 'Posaconazole 18 MG/ML' | Standard of Care |
|---|---|---|
| ExplanationInfections and infestations | — | — |
| Age, Categorical(Participants) | SOC + 'Posaconazole 18 MG/ML' | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 20 | 45 |
| >=65 years | 12 | 16 | 28 |
| Age, Continuous(years) | SOC + 'Posaconazole 18 MG/ML' | Standard of Care | Total |
|---|---|---|---|
| Mean | 59 ± 16 | 63 ± 15 | 61 ± 15 |
| Sex: Female, Male(Participants) | SOC + 'Posaconazole 18 MG/ML' | Standard of Care | Total |
|---|---|---|---|
| Female | 14 | 18 | 32 |
| Male | 23 | 18 | 41 |
| Ethnicity (NIH/OMB)(Participants) | SOC + 'Posaconazole 18 MG/ML' | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 37 | 36 | 73 |
| Race (NIH/OMB)(Participants) | SOC + 'Posaconazole 18 MG/ML' | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 25 | 25 | 50 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 9 | 20 |
| Region of Enrollment(participants) | SOC + 'Posaconazole 18 MG/ML' | Standard of Care | Total |
|---|---|---|---|
| Netherlands | 1 | 4 | 5 |
| Belgium | 34 | 27 | 61 |
| France | 2 | 5 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Mar 2020, 27 months.
Results were first posted in Apr 2025, 5 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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