AspergillosisASPERGIGRIPPNCT04232956
Invasive Pulmonary Aspergillosis and Severe Influenza
An observational study of Aspergillosis and Influenza, run by University Hospital, Brest at 4 sites in France.
Trial summary
Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspergillosis, Influenza, Critical Illness
- How many people
- 478 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Jul 2018to 5 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Critically ill patients with influenza infection
Who may be able to join
- Infection with influenza A or B
- Admission to one of the participating sites
Who cannot join
- age < 18
- patients with invasive pulmonary aspergillosis prior to intensive care admission
- consent withdraw
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHRU de Brest
Brest, 29609
CHR
Morlaix
CHU de NANTES
Nantes, 44000
CHU de Rennes
Rennes, 35033
About this study
Official title: Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?
Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.
Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.
- Conditions
- Aspergillosis, Influenza, Critical Illness
- Medical subject headings
- Aspergillosis, Influenza, Human, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Pulmonary Aspergillosis
incidence of invasive pulmonary aspergillosis
Measured: up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start27 Jul 2018
- Primary completion5 Nov 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232956
- Sponsor's protocol ID
- ASPERGIGRIPP (29BRC18.0069)
- Acronym
- ASPERGIGRIPP
- Status last verified
- Jan 2020
- First submitted
- 10 Jul 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?
- ClinicalTrials.gov ID
- NCT04232956
- Acronym / sponsor ID
- ASPERGIGRIPP / ASPERGIGRIPP (29BRC18.0069)
- Conditions
- Aspergillosis, Influenza, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 18 Jan 2020 (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.
Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.
Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with influenza infection
Key inclusion criteria (2 listed)
- Infection with influenza A or B
- Admission to one of the participating sites
Key exclusion criteria (3 listed)
- age < 18
- patients with invasive pulmonary aspergillosis prior to intensive care admission
- consent withdraw
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Invasive Pulmonary Aspergillosis
Time frame: up to 100 days
incidence of invasive pulmonary aspergillosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Aspergillosis
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A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspergillosis and Influenza, run by University Hospital, Brest at 4 sites in France.
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 3 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: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Pulmonary Aspergillosis (time frame: up to 100 days). 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 18 Jan 2020.