Invasive Pulmonary AspergillosisITBANCT04077697
Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.
An observational study of Invasive Pulmonary Aspergillosis and Morality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Invasive tracheobronchial aspergillosis (ITBA) is an uncommon, but severe clinical form of Invasive Pulmonary Aspergillosis (IPA) in which the fungal infection is entirely or predominantly confined to the tracheobronchial tree. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Pulmonary Aspergillosis, Morality
- What is being tested?
- RT-PCR for influenza
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 16 Jul 2019
- 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: Patients eligible for inclusion were patients with a diagnosis of influenza confirmed by a positive influenza real time polymerase chain reaction (RT-PCR) from nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid, with a concomitant diagnosis of proven or probable/putative IPA and the performing of a bronchoscopy
Who may be able to join
- all ICU (Intensive care unit) patients
- patients aged from 18 years and more
- All patients hospitalized in ICU with a positive influenza RT-PCR extracted from the registry of the local virology department
- patients with a diagnosis of influenza confirmed by a positive influenza real time polymerase chain reaction (RT-PCR) from nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid, with a concomitant diagnosis of proven or probable/putative IPA and the performing of a bronchoscopy
Who cannot join
- minor or adult with guardianship
- absence of hospitalization in intensive care
- influenza infection not confirmed by PCR
Trial locations and contacts
1 site in 1 country.
About this study
Invasive tracheobronchial aspergillosis (ITBA) is an uncommon, but severe clinical form of Invasive Pulmonary Aspergillosis (IPA) in which the fungal infection is entirely or predominantly confined to the tracheobronchial tree. In view of the limited data concerning critically ill patients admitted to the intensive care unit (ICU) with severe influenza associated with ITBA, the investigators decided to evaluate the differences between the clinical presentations of two invasive infections: ITBA and IPA without tracheobronchial involvement (No ITBA).
Read the detailed description
Invasive pulmonary aspergillosis (IPA) is a well-known complication in severely immunocompromised hosts patients. Recent evidence has identified others populations at risk for IPA, including those with chronic obstructive pulmonary disease (COPD) and advanced cirrhosis patients in intensive care units (ICUs). Moreover, Recently influenza has been identified as a new independent risk factor for IPA and IPA was described as an early complication of influenza. IPA groups different clinical presentations: the classical angio-invasive, the broncho-invasive form and the invasive tracheobronchitis aspergillosis form (ITBA).
ITBA is an infrequent clinical form of IPA with often a fatal outcome, in which Aspergillus infection involves entirely or predominantly the tracheobronchial tree. Early diagnosis of ITBA is based on bronchoscopy examination. Severe influenza is a life-threatening condition where IPA has been repeatedly reported. Little is known on severe influenza infection complicated with IPA and still less with ITBA. Current data on ITBA in critically ill patients hospitalized for severe influenza infection has only been described in single case reports. Because ITBA has been associated with a poorer prognostic than other forms of IPA, this retrospective study aimed to analyze diagnostic and prognostic differences between ITBA and IPA without tracheobronchial lesions, in critically ill patients with influenza infection hospitalized in ICU.
- Conditions
- Invasive Pulmonary Aspergillosis, Morality
- Being tested
- RT-PCR for influenza
- Keywords
- invasive pulmonary aspergillosis, Invasive TracheoBronchial Aspergillosis, galactomannan, 1,3-β-D-Glucan, influenza, Intensive Care Unit, mortality
- Medical subject headings
- Invasive Pulmonary Aspergillosis, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-PCR for influenzaDiagnostic test
influenza real time polymerase chain reaction (RT-PCR) from a nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid.
| Study group | Role | What they receive |
|---|---|---|
| ITBA group | ITBA group is : invasive tracheobronchitis aspergillosis form. Receives: Diagnostic Test: RT-PCR for influenza | |
| IPA without tracheobronchial involvement | IPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement Receives: Diagnostic Test: RT-PCR for influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of management of ITBA diagnosis criteria
Evolution of the diagnosis criteria of the ITBA
Measured: from day 0 to two weeks after the start of the study
Secondary outcomes (2)
Change of management of ITBA prognosis
Evolution of ITBA prognosis
Measured: from day 0 to two weeks after the start of the study
Change of mortality rate between ITBA group and IPA group
ITBA group is : invasive tracheobronchitis aspergillosis form. IPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement
Measured: from day 0 to two weeks after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Jul 2019
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, Centre Hospitalier de Lens
- Responsible party
- Sponsor
- Investigators
- Elie Zogheib, MD, Principal investigator, CHU AmiensTaieb Chouaki, MD, Principal investigator, CHU AmiensHervé Dupont, Pr, Principal investigator, CHU AmiensJulien Maizel, Pr, Principal investigator, CHU AmiensRémy Nyga, MD, Principal investigator, CHU AmiensIvona Milic, MD, Principal investigator, CHU AmiensSaad NSEIR, Pr, Principal investigator, CHU LilleBoualem SENDID, Pr, Principal investigator, CHU Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077697
- Sponsor's protocol ID
- PI2019_843_0047
- Acronym
- ITBA
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nyga R, Maizel J, Nseir S, Chouaki T, Milic I, Roger PA, Van Grunderbeeck N, Lemyze M, Totet A, Castelain S, Slama M, Dupont H, Sendid B, Zogheib E. Invasive Tracheobronchial Aspergillosis in Critically Ill Patients with Severe Influenza. A Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):708-716. doi: 10.1164/rccm.201910-1931OC.
PubMed 32407157
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT04077697
- Acronym / sponsor ID
- ITBA / PI2019_843_0047
- Conditions
- Invasive Pulmonary Aspergillosis, Morality
- Keywords
- invasive pulmonary aspergillosis, Invasive TracheoBronchial Aspergillosis, galactomannan, 1,3-β-D-Glucan, influenza, Intensive Care Unit, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Lille, Centre Hospitalier de Lens
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 4 Sep 2019 (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 tracheobronchial aspergillosis (ITBA) is an uncommon, but severe clinical form of Invasive Pulmonary Aspergillosis (IPA) in which the fungal infection is entirely or predominantly confined to the tracheobronchial tree. In view of the limited data concerning critically ill patients admitted to the intensive care unit (ICU) with severe influenza associated with ITBA, the investigators decided to evaluate the differences between the clinical presentations of two invasive infections: ITBA and IPA without tracheobronchial involvement (No ITBA).
Detailed description
Invasive pulmonary aspergillosis (IPA) is a well-known complication in severely immunocompromised hosts patients. Recent evidence has identified others populations at risk for IPA, including those with chronic obstructive pulmonary disease (COPD) and advanced cirrhosis patients in intensive care units (ICUs). Moreover, Recently influenza has been identified as a new independent risk factor for IPA and IPA was described as an early complication of influenza. IPA groups different clinical presentations: the classical angio-invasive, the broncho-invasive form and the invasive tracheobronchitis aspergillosis form (ITBA).
ITBA is an infrequent clinical form of IPA with often a fatal outcome, in which Aspergillus infection involves entirely or predominantly the tracheobronchial tree. Early diagnosis of ITBA is based on bronchoscopy examination. Severe influenza is a life-threatening condition where IPA has been repeatedly reported. Little is known on severe influenza infection complicated with IPA and still less with ITBA. Current data on ITBA in critically ill patients hospitalized for severe influenza infection has only been described in single case reports. Because ITBA has been associated with a poorer prognostic than other forms of IPA, this retrospective study aimed to analyze diagnostic and prognostic differences between ITBA and IPA without tracheobronchial lesions, in critically ill patients with influenza infection hospitalized in ICU.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITBA group | – | Diagnostic Test: RT-PCR for influenzaITBA group is : invasive tracheobronchitis aspergillosis form. |
| IPA without tracheobronchial involvement | – | Diagnostic Test: RT-PCR for influenzaIPA group is : invasive pulmonary aspergillosis without tracheobronchial involvement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for inclusion were patients with a diagnosis of influenza confirmed by a positive influenza real time polymerase chain reaction (RT-PCR) from nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid, with a concomitant diagnosis of proven or probable/putative IPA and the performing of a bronchoscopy
Key inclusion criteria (4 listed)
- all ICU (Intensive care unit) patients
- patients aged from 18 years and more
- All patients hospitalized in ICU with a positive influenza RT-PCR extracted from the registry of the local virology department
- patients with a diagnosis of influenza confirmed by a positive influenza real time polymerase chain reaction (RT-PCR) from nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid, with a concomitant diagnosis of proven or probable/putative IPA and the performing of a bronchoscopy
Key exclusion criteria (3 listed)
- minor or adult with guardianship
- absence of hospitalization in intensive care
- influenza infection not confirmed by PCR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-PCR for influenzainfluenza real time polymerase chain reaction (RT-PCR) from a nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid. | Diagnostic test | IPA without tracheobronchial involvement, ITBA group |
Primary outcome
Change of management of ITBA diagnosis criteria
Time frame: from day 0 to two weeks after the start of the study
Evolution of the diagnosis criteria of the ITBA
2 secondary outcomes
Change of management of ITBA prognosis
Time frame: from day 0 to two weeks after the start of the study
Change of mortality rate between ITBA group and IPA group
Time frame: from day 0 to two weeks after the start of the study
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 4 Sep 2019.
- Derived from this study: PubMed 32407157Nyga R, Maizel J, Nseir S, Chouaki T, Milic I, Roger PA, Van Grunderbeeck N, Lemyze M, Totet A, Castelain S, Slama M, Dupont H, Sendid B, Zogheib E. Invasive Tracheobronchial Aspergillosis in Critically Ill Patients with Severe Influenza. A Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):708-716. doi: 10.1164/rccm.201910-1931OC.
- Individual participant dataSharing planned: No
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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.
Elie Zogheib, MD principal investigator
CHU Amiens
Taieb Chouaki, MD principal investigator
CHU Amiens
Hervé Dupont, Pr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Pulmonary Aspergillosis and Morality, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 4 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change of management of ITBA diagnosis criteria (time frame: from day 0 to two weeks after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077697, which also lists 1 linked publication.
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 4 Sep 2019.