Prospective Observational Trial of IAPA (NCT04530799) | Clinical Trial Compass
CompletedNot Applicable
Prospective Observational Trial of IAPA
Belgium, France, Netherlands241 participantsStarted 2022-03-10
Plain-language summary
A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a PCR-positive respiratory virus panel (RVP) result for influenza within 96 hours before or 48 hours after ICU admission.
* Patients who require ICU admission for more than 24 hours for severe influenza.
* Patients who have respiratory distress (respiratory rate \>= 25x/minute and paO2/fiO2 \< 300 with or without bilateral infiltrates) as the main reason for ICU admission.
* Patients who do not have an EORTC host factor.
* Patients who are at least 18 years of age.
Exclusion Criteria:
* Patients with age \< 18 years as extensive sampling is required
* Expected survival on ICU admission ≤ 48h
* Patients that are being treated actively with antifungal agents for invasive aspergillosis.
* Patients or their legal representatives who did not sign the informed consent form
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was tracking how often patients in the ICU developed a fungal lung infection called Aspergillosis on top of influenza pneumonia — since the study is now completed, has my doctor seen the results, and what do they tell us about how common this combined infection actually is?
2Since this was an observational study that watched what happened rather than testing a new treatment, does my doctor think the findings change how they would monitor or test me for Aspergillosis if I have influenza with pneumonia?
3The trial measured infection rates at ICU discharge — does that mean there are gaps in what we know about what happens to patients after they leave the ICU, and should my doctor be watching for signs of Aspergillosis beyond my hospital stay?
4Given that this study focused specifically on ICU patients with influenza and pneumonia, does my doctor think its findings apply to my particular situation, or are there reasons my case might be different from the patients in this trial?
5Are there standard screening or treatment protocols for this type of fungal infection that my care team already follows, and did this completed trial add anything new that might change how my doctor approaches my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of IAPA-infection at ICU discharge
Timeframe: from date of admission in ICU assessed up to ICU discharge, approximately 21 days