An observational study in Influenza With Pneumonia and Aspergillosis Invasive, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
Among 14 studies in Aspergillosis with a site in Belgium — 1 open to participants now, 1 under way, none of them phase 3. Aspergillosis · Belgium.
Among the 14 studies in Aspergillosis with a site in Belgium, this one is the only one that started in 2018, is the only observational one, and was the 8th registered.
134 studies on the registry are indexed under Aspergillosis; 10 are open to participants now.
This study's enrollment of 298 is above the median of 200 across 51 observational studies indexed under Aspergillosis.
Browse Aspergillosis studies →1 of the 14 studies in Aspergillosis with a site in Belgium is open now, in 3 countries. 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 →14 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2018.
Median enrollment 66 across the 13 interventional studies, 298 across the 1 observational. Of the 13 that completed or were terminated, 9 (69%) have results posted.
8 of 14 have an industry lead sponsor. The 10 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.
1 of the studies in Aspergillosis with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03828773Bochud Pierre-YvesPTX3-targeted Antifungal Prophylaxis | 2027-11-30 |
Among the 14 studies in Aspergillosis with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
Study the incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza and in influenza-negative control patients with severe community-acquired pneumonia
This prospective multicentre case-control registration study in Dutch and Belgian ICUs will assess the difference in incidence and outcome of invasive pulmonary aspergillosis (IPA) in ICU patients with severe influenza compared with influenza-negative control patients with severe community-acquired pneumonia during the coming three influenza seasons (2017-2020). The study will further assess the differences in clinical characteristics and risk factors between influenza patients with and without invasive aspergillosis.
All consecutive patients aged 18 or older admitted to ICU during the inclusion period with respiratory distress due to influenza positive/negative community acquired pneumonia (CAP) will be included.
All consecutive patients admitted from home to ICU with respiratory distress, with documented pulmonary infiltrates and initiation of antimicrobial therapy because community acquired pneumonia is the primary diagnosis or in the differential diagnosis.
Confirmation of presence or absence of influenza is based on probe-based reverse-transcriptase polymerase chain reaction (RT-PCR) for influenza A or B directly on sputum, bronchial aspirate, broncho-alveolar (BAL) fluid or a nasopharyngeal swab.
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.
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.
All consecutive patients older than 18 years ,admitted to the ICU with respiratory distress with microbiologically confirmed diagnosis of influenza
All consecutive patients older than 18 years, admitted to the ICU for respiratory distress due to community-acquired pneumonia (CAP) and with a microbiologically confirmed absence of influenza,
incidence IPA between ICU patients with severe influenza and in influenza-negative control patients
incidence of mycological evidence of Aspergillus and at least one Aspergillus compatible sign or symptom and radiological abnormalities based on Chest CT or Chest X ray. Mycological evidence can be provided by either (A) a positive culture of Aspergillus cultured from bronchoalveolar lavage (BAL) sample, (B) ≥2 positive cultures of Aspergillus cultured from a sputum or a bronchial aspirate or (C) a galactomannan (GM) optical density of ≥1 in BAL or ≥0.5 in serum. Aspergillus compatible signs or symptoms are defined as at least one of the following: * Worsening respiratory insufficiency in spite of proper antibiotic and ventilator support * Dyspnea * Haemoptysis * Fever refractory to at least 3 days of appropriate antibiotic (AB) therapy. Recrudescent fever after a period of defervescence of at least 48 h while still on AB without apparent cause. The presence of hyphae in lung biopsy or autopsy are also considered as sufficient evidence for IPA.
Time frame: from date of admission in ICU assessed up to ICU discharge, approximately 21 days
variations in baseline factors and risk factors between influenza and non-influenza patients in ICU
difference in baseline factors: demographic, biochemical, microbiological and radiological data
Time frame: from date of admission in ICU to date of ICU discharge, approximately 21 days
rate of IPA disease progression
rate of IPA disease progression in the subgroup of patients with IPA
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
rate of presence of azole resistance
rate of presence of azole resistance in the subgroup of patients with IPA
Time frame: from date of admission to ICU to date of discharge from ICU, approximately 21 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Jun 2021, 41 months.
Of 19 observational studies under Aspergillosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 41 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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