Invasive Mold InfectionsBIMINCT04720144
Breakthrough Invasive Mold Infections Under Posaconazole Prophylaxis (BIMI)
An observational study of Invasive Mold Infections and Breakthrough Invasive Mold Infections, run by Centre Hospitalier Universitaire Vaudois at 8 sites in 3 countries.
Trial summary
Invasive mold infections (IMI) mainly affect patients with hematologic malignancies receiving intensive chemotherapy or after hematopoietic stem cell transplantation (HSCT). Prolonged neutropenia after remission induction chemotherapy (>10 days duration) and continuous immunosuppression in the context of prevention or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mold Infections, Breakthrough Invasive Mold Infections, Hematologic Malignancy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 300 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 1 Oct 2020to 30 Sep 2022
- 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: Adults diagnosed with hematologic malignancies under posaconazole prophylaxis for one of the above mentionned reasons.
Who may be able to join
- Cases:
- Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis (oral tablets or IV administration) for:
- Induction, consolidation or re-induction chemotherapy for acute leukemia or myelodysplastic syndrome (i.e. expected duration of neutropenia post-chemotherapy of ≥ 10 days)
- OR
- Allogeneic hematopoietic stem cell transplant recipients during the post-transplantation phase (100-day post-transplantation) or later in case of intensified immunosuppression for moderate to severe graft vs host disease (GVHD).
- AND
Show all 14Show fewer
- Being diagnosed with proven or probable bIMI according to the EORTC-MSG classification (10) while on continuous posaconazole prophylaxis for at least 7 days.
- Controls:
- For each bIMI case, we will include 2 control cases fulfilling the following criteria:
- Receiving continuous posaconazole prophylaxis for at least 7 days
- No diagnosis of proven, probable or possible IMI according to EORTC-MSG classification (10) during the entire hospital stay.
- And matched to bIMI cases according to the following criteria:
- Hospitalization in the same ward within the same year (+/- 12 months interval)
- Same underlying condition related to hematologc cancer: a) HSCT within 100 days post-engraftment, b) HSCT > 100 days post-engraftment with intensified immunosuppressive regimen for severe GVHD, c) induction chemotherapy for acute myeloid or lymphoid leukemia, or myelodysplastic syndrome, d) other hematologic disorders (e.g. aplastic anemia) with prolonged neutropenia and/or immunosuppressive regimen.
Who cannot join
- Patients with a diagnosis of possible IMI according to the EORTC-MSG classification.
- Patients with a positive fungal biomarker in serum (e.g. galactomannan or beta-glucan) in the absence of clinical or radiological criteria of IMI according to the EORTC-MSG classification.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Switzerland6 sites, 6 recruiting
- Recruiting
Universitätsspital Basel
Basel
Nina Khanna
- Recruiting
Inselspital Bern
Bern
Stefan Zimmerli
- Recruiting
Hôpital Cantonal de Fribourg
Fribourg
Véronique Erard
- Recruiting
Hôpitaux Universitaires de Genève (HUG)
Geneva
Dionysios Neofytos
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne
Frederic Lamoth, +41213141111, frederic.lamoth@chuv.ch
- Not yet recruiting
Kantonsspital St.Gallen
Sankt Gallen
Kattia Boggian
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Innsbruck
Innsbruck
Cornelia Lass-Flörl
Germany1 site, 1 recruiting
- Not yet recruiting
University Hospital Cologne
Cologne
Jannick Stemler
About this study
Official title: Multicenter Case-control Study of Breakthrough Invasive Mold Infections Under Posaconazole Prophylaxis
Invasive mold infections (IMI) mainly affect patients with hematologic malignancies receiving intensive chemotherapy or after hematopoietic stem cell transplantation (HSCT). Prolonged neutropenia after remission induction chemotherapy (>10 days duration) and continuous immunosuppression in the context of prevention or therapy of graft versus host disease (GVHD) for HSCT recipients (first 100 days post-transplantation and thereafter if GVHD is present) are considered as periods at high risk of IMI.
Posaconazole prophylaxis is prescribed according to current guidelines to reduce the occurrence of IMI. Nevertheless, breakthrough IMI (bIMI), i.e. IMI occurring under mold-active prophylaxis, are still observed.
Read more
The investigators hypothesized that the epidemiology of bIMI (under posaconazole prophylaxis) differs from that of IMI occurring in the absence of mold-active antifungal prophylaxis. Because bIMI are rare events since the introduction of posaconazole prophylaxis, epidemiological data of bIMI are scarce.
This study aims to i) describe the epidemiology, clinical features, treatment and outcome of bIMI, ii) assess the causes of bIMI, iii) determine potential risk factors associated with the developllement of bIMI iv) assess the impact of bIMI on overall mortality.
Design
Retrospective and prospective, observational, case-control, multicenter, international study.
The retrospective part will enroll previously identified bIMI cases and control cases (1:2) over the last five years: October 1st 2015 to September 30st 2020.
The prospective part will enroll bIMI cases and control cases (1:2) occurring over a two-year period: October 1st 2020 to September 30st 2022.
Setting
The aim is to enroll 10 to 15 European centers with dedicated units for hematologic cancer patients. Currently, six centers have confirmed their participation (from Switzerland and Germany).
Study Population
Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis during induction, consolidation or re-induction chemotherapy or after HSCT.
Cases : patients receiving posaconazole prophylaxis for at least 7 days and diagnosed with bIMI proven or probable according to EORTC-MSGERC.
Controls: patients receiving posaconazole prophylaxis for at least 7 days, without diagnosis of bIMI possible, probable or proven according to EORTC-MSGERC.
The objective is to enroll about 100 bIMI cases and 200 controls.
- Conditions
- Invasive Mold Infections, Breakthrough Invasive Mold Infections, Hematologic Malignancy, Hematologic Diseases
- Keywords
- Posaconazole, Antifungal prophylaxis
- Medical subject headings
- Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| bIMI cases | Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis (oral tablets or IV administration) for: i) Induction, consolidation or re-induction chemotherapy for acute leukemia or myelodysplastic syndrome (i.e. expected duration of neutropenia post-chemotherapy of ≥ 10 days) OR ii) Allogeneic hematopoietic stem cell transplant recipients during the post-transplantation phase (100-day post-transplantation) or later in case of intensified immunosuppression for moderate to severe graft vs host disease (GVHD). AND iii) Being diagnosed with proven or probable bIMI according to the EORTC-MSGERC classification (10) while on continuous posaconazole prophylaxis for at least 7 days. | |
| Controls | For each bIMI case, we will include 2 control cases fulfilling the following criteria: i) Receiving continuous posaconazole prophylaxis for at least 7 days ii) No diagnosis of proven, probable or possible IMI according to EORTC-MSGERC classification (10) during the entire hospital stay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological description of bIMI
- Assessment of the cause of bIMI (intrinsically resistant mold pathogen vs susceptible mold pathogen but insufficient posaconazole serum concentration vs unknown)
- Description of clinical features, treatment and outcome of bIMI
Measured: At inclusion
Assessment of the risk factors of bIMI
- Univariate and multivariate analyses of the parameters associated with an increased risk of bIMI (in particular, the association of a threshold of posaconazole concentration and bIMI) by comparison of bIMI cases with controls (posaconazole prophylaxis and no bIMI)
Measured: At inclusion
Secondary outcomes (2)
Assessment of the impact of bIMI on overall mortality
- Comparison of mortality rate (6 and 12 weeks) between bIMI and control cases.
Measured: 6 weeks and 12 weeks after inclusion
Assessment of factors influencing outcomes of bIMI
- Univariate and multivariate analysis of predictors of mortality (6 and 12 weeks) among bIMI cases.
Measured: 6 weeks and 12 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Oct 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mold InfectionsStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederic Lamoth, Centre Hospitalier Universitaire Vaudois
- Investigators
- Frederic Lamoth, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720144
- Sponsor's protocol ID
- 2020-01719
- Acronym
- BIMI
- Status last verified
- Feb 2021
- First submitted
- 19 Jan 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Case-control Study of Breakthrough Invasive Mold Infections Under Posaconazole Prophylaxis
- ClinicalTrials.gov ID
- NCT04720144
- Acronym / sponsor ID
- BIMI / 2020-01719
- Conditions
- Invasive Mold Infections, Breakthrough Invasive Mold Infections, Hematologic Malignancy, Hematologic Diseases
- Keywords
- Posaconazole, Antifungal prophylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 22 Jan 2021 (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 mold infections (IMI) mainly affect patients with hematologic malignancies receiving intensive chemotherapy or after hematopoietic stem cell transplantation (HSCT). Prolonged neutropenia after remission induction chemotherapy (>10 days duration) and continuous immunosuppression in the context of prevention or therapy of graft versus host disease (GVHD) for HSCT recipients (first 100 days post-transplantation and thereafter if GVHD is present) are considered as periods at high risk of IMI.
Posaconazole prophylaxis is prescribed according to current guidelines to reduce the occurrence of IMI. Nevertheless, breakthrough IMI (bIMI), i.e. IMI occurring under mold-active prophylaxis, are still observed.
The investigators hypothesized that the epidemiology of bIMI (under posaconazole prophylaxis) differs from that of IMI occurring in the absence of mold-active antifungal prophylaxis. Because bIMI are rare events since the introduction of posaconazole prophylaxis, epidemiological data of bIMI are scarce.
This study aims to i) describe the epidemiology, clinical features, treatment and outcome of bIMI, ii) assess the causes of bIMI, iii) determine potential risk factors associated with the developllement of bIMI iv) assess the impact of bIMI on overall mortality.
Design
Retrospective and prospective, observational, case-control, multicenter, international study.
The retrospective part will enroll previously identified bIMI cases and control cases (1:2) over the last five years: October 1st 2015 to September 30st 2020.
The prospective part will enroll bIMI cases and control cases (1:2) occurring over a two-year period: October 1st 2020 to September 30st 2022.
Setting
The aim is to enroll 10 to 15 European centers with dedicated units for hematologic cancer patients. Currently, six centers have confirmed their participation (from Switzerland and Germany).
Study Population
Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis during induction, consolidation or re-induction chemotherapy or after HSCT.
Cases : patients receiving posaconazole prophylaxis for at least 7 days and diagnosed with bIMI proven or probable according to EORTC-MSGERC.
Controls: patients receiving posaconazole prophylaxis for at least 7 days, without diagnosis of bIMI possible, probable or proven according to EORTC-MSGERC.
The objective is to enroll about 100 bIMI cases and 200 controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bIMI cases | – | –Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis (oral tablets or IV administration) for: i) Induction, consolidation or re-induction chemotherapy for acute leukemia or myelodysplastic syndrome (i.e. expected duration of neutropenia post-chemotherapy of ≥ 10 days) OR ii) Allogeneic hematopoietic stem cell transplant recipients during the post-transplantation phase (100-day post-transplantation) or later in case of intensified immunosuppression for moderate to severe graft vs host disease (GVHD). AND iii) Being diagnosed with proven or probable bIMI according to the EORTC-MSGERC classification (10) while on continuous posaconazole prophylaxis for at least 7 days. |
| Controls | – | –For each bIMI case, we will include 2 control cases fulfilling the following criteria: i) Receiving continuous posaconazole prophylaxis for at least 7 days ii) No diagnosis of proven, probable or possible IMI according to EORTC-MSGERC classification (10) during the entire hospital stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with hematologic malignancies under posaconazole prophylaxis for one of the above mentionned reasons.
Key inclusion criteria (14 listed)
- Cases:
- Adult (≥ 18 years old) patients with a hematologic malignancy receiving posaconazole prophylaxis (oral tablets or IV administration) for:
- Induction, consolidation or re-induction chemotherapy for acute leukemia or myelodysplastic syndrome (i.e. expected duration of neutropenia post-chemotherapy of ≥ 10 days)
- OR
- Allogeneic hematopoietic stem cell transplant recipients during the post-transplantation phase (100-day post-transplantation) or later in case of intensified immunosuppression for moderate to severe graft vs host disease (GVHD).
Key exclusion criteria (2 listed)
- Patients with a diagnosis of possible IMI according to the EORTC-MSG classification.
- Patients with a positive fungal biomarker in serum (e.g. galactomannan or beta-glucan) in the absence of clinical or radiological criteria of IMI according to the EORTC-MSG classification.
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
Epidemiological description of bIMI
Time frame: At inclusion
* Assessment of the cause of bIMI (intrinsically resistant mold pathogen vs susceptible mold pathogen but insufficient posaconazole serum concentration vs unknown) * Description of clinical features, treatment and outcome of bIMI
Assessment of the risk factors of bIMI
Time frame: At inclusion
• Univariate and multivariate analyses of the parameters associated with an increased risk of bIMI (in particular, the association of a threshold of posaconazole concentration and bIMI) by comparison of bIMI cases with controls (posaconazole prophylaxis and no bIMI)
2 secondary outcomes
Assessment of the impact of bIMI on overall mortality
Time frame: 6 weeks and 12 weeks after inclusion
Assessment of factors influencing outcomes of bIMI
Time frame: 6 weeks and 12 weeks after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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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.
Frederic Lamoth principal investigator
Centre Hospitalier Universitaire Vaudois
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Mold Infections and Breakthrough Invasive Mold Infections, run by Centre Hospitalier Universitaire Vaudois at 8 sites in 3 countries.
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 14 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, Austria, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederic Lamoth (+41213141111, frederic.lamoth@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological description of bIMI (time frame: At inclusion). The study lists 2 primary outcomes in all. 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 9 Feb 2021.