Invasive AspergillosisCLARITYNCT03221075
Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy
An observational study of Invasive Aspergillosis, run by University Hospital of Cologne at 2 sites in 2 countries.
Trial summary
In order to determine the efficacy of antifungal therapy in patients with documented azole-resistant invasive Aspergillosis (IA), anonymized clinical information of patients with a hematological malignancy with a culture-positive invasive fungal infection caused by Aspergillus fumigatus are collected in an online… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- Registry
- How many people
- 203 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Mar 2017to 25 Oct 2022
- How long will I take part?
- 4 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases will be recruited worldwide.
Who may be able to join
- Adult and pediatric patients diagnosed with an IA in 2016 and later
- Patients with a hematological malignancy
- Evidence of invasive Aspergillosis
- Aspergillus fumigatus culture from clinical material of the patient
Who cannot join
- Colonization only, without proof of invasive infection
- Non-availability of the azole resistant isolate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50931
Netherlands1 site
Radboud University Nijmegen Medical Center
Nijmegen, 6500
About this study
Official title: CLARITY - Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy
In order to determine the efficacy of antifungal therapy in patients with documented azole-resistant invasive Aspergillosis (IA), anonymized clinical information of patients with a hematological malignancy with a culture-positive invasive fungal infection caused by Aspergillus fumigatus are collected in an online registry. Respective fungal isolates are analysed for azole susceptibility and resistance mechanisms. Patients diagnosed with an IA in 2016 and later are included in the study.
Read the detailed description
For mold-active azoles (e.g. isavuconazole, itraconazole, posaconazole and voriconazole), cross-resistance of Aspergillus spp. is an increasingly recognized problem. The study aims to determine the efficacy of antifungal therapy in patients with documented azole-resistant IA. On the basis of this study, it will be possible to assess the clinical implications of IA caused by azole-resistant versus azole-susceptible Aspergillus spp.
The investigators aim at collecting at least 55 azole-resistant and 130 azole-susceptible cases. Cases diagnosed with an IA by culture from January 1st, 2016 onwards with an underlying hematological malignancy are eligible for inclusion. Culture of azole-resistant cases must be provided for confirmation of the species, sequencing for azole-resistance mutations and determination of MIC using the EUCAST reference method. Isolates obtained from patients with presumed azole-susceptible disease will be analyzed to confirm the wild type phenotype.
Eligible azole-resistant and azole-susceptible IA cases will be documented using the web-based case report form. If there is ≥1 resistant isolate, the patient fulfills the definition of a resistant case. Patient level data will be recorded at the respective study centres in a continuous fashion. Data items to be documented will include: demographic data; type and status of underlying conditions; concurrent immunosuppressive treatment; diagnostic measures (clinical presentation, radiology, microbiology, pathology, organ involvement); medical and surgical treatment (including prior exposure to antifungals); response to treatment (clinical and radiological) at day 14, 42, 84; overall survival at day 14, 42, 84 and at last contact; and cause of death (if applicable).
- Conditions
- Invasive Aspergillosis
- Being tested
- Registry
- Keywords
- Invasive Aspergillosis, Azole resistance, Aspergillus fumigatus, Efficacy of antifungal therapy, Patient registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Invasive Aspergillosis | Not described Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response to antifungal therapy in patients with an invasive Aspergillosis caused by an azole resistant pathogen.
Analysis of efficacy of antifungal therapy of azole-resistant and azole-susceptible invasive Aspergillosis. Patient receive either complete response, partial response, stable disease, progression of the disease. Treatment response will be assessed by treating physicians. Response will be compared between the two groups.
Measured: Change from diagnosis at day 14, 28, 42 and 84 and throughout study completion
Secondary outcomes (1)
Overall survival
Final outcome will be compared between the two groups in consideration of the type and state of underlying diseases and risk factors.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Mar 2017
- Primary completion30 Apr 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive AspergillosisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Principal investigator, Prof. Dr. Oliver A. Cornely, University Hospital of Cologne
- Investigators
- Oliver A. Cornely, Prof., Principal investigator, University Hospital of Cologne, GermanyPaul E. Verweij, Prof., Principal investigator, Radboud University Nijmegen Medical Center, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221075
- Sponsor's protocol ID
- 17-024
- Acronym
- CLARITY
- Status last verified
- May 2023
- First submitted
- 9 May 2017
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with unauthorized persons. Anonymized data will only be exchanged between study coordinators and the analysis team.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLARITY - Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy
- ClinicalTrials.gov ID
- NCT03221075
- Acronym / sponsor ID
- CLARITY / 17-024
- Conditions
- Invasive Aspergillosis
- Keywords
- Invasive Aspergillosis, Azole resistance, Aspergillus fumigatus, Efficacy of antifungal therapy, Patient registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 18 Jul 2017 (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.
In order to determine the efficacy of antifungal therapy in patients with documented azole-resistant invasive Aspergillosis (IA), anonymized clinical information of patients with a hematological malignancy with a culture-positive invasive fungal infection caused by Aspergillus fumigatus are collected in an online registry. Respective fungal isolates are analysed for azole susceptibility and resistance mechanisms. Patients diagnosed with an IA in 2016 and later are included in the study.
Detailed description
For mold-active azoles (e.g. isavuconazole, itraconazole, posaconazole and voriconazole), cross-resistance of Aspergillus spp. is an increasingly recognized problem. The study aims to determine the efficacy of antifungal therapy in patients with documented azole-resistant IA. On the basis of this study, it will be possible to assess the clinical implications of IA caused by azole-resistant versus azole-susceptible Aspergillus spp.
The investigators aim at collecting at least 55 azole-resistant and 130 azole-susceptible cases. Cases diagnosed with an IA by culture from January 1st, 2016 onwards with an underlying hematological malignancy are eligible for inclusion. Culture of azole-resistant cases must be provided for confirmation of the species, sequencing for azole-resistance mutations and determination of MIC using the EUCAST reference method. Isolates obtained from patients with presumed azole-susceptible disease will be analyzed to confirm the wild type phenotype.
Eligible azole-resistant and azole-susceptible IA cases will be documented using the web-based case report form. If there is ≥1 resistant isolate, the patient fulfills the definition of a resistant case. Patient level data will be recorded at the respective study centres in a continuous fashion. Data items to be documented will include: demographic data; type and status of underlying conditions; concurrent immunosuppressive treatment; diagnostic measures (clinical presentation, radiology, microbiology, pathology, organ involvement); medical and surgical treatment (including prior exposure to antifungals); response to treatment (clinical and radiological) at day 14, 42, 84; overall survival at day 14, 42, 84 and at last contact; and cause of death (if applicable).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasive Aspergillosis | – | Other: Registry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases will be recruited worldwide.
Key inclusion criteria (4 listed)
- Adult and pediatric patients diagnosed with an IA in 2016 and later
- Patients with a hematological malignancy
- Evidence of invasive Aspergillosis
- Aspergillus fumigatus culture from clinical material of the patient
Key exclusion criteria (2 listed)
- Colonization only, without proof of invasive infection
- Non-availability of the azole resistant isolate
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 |
|---|---|---|
| RegistryThere is no intervention. | Other | Invasive Aspergillosis |
Primary outcome
Treatment response to antifungal therapy in patients with an invasive Aspergillosis caused by an azole resistant pathogen.
Time frame: Change from diagnosis at day 14, 28, 42 and 84 and throughout study completion
Analysis of efficacy of antifungal therapy of azole-resistant and azole-susceptible invasive Aspergillosis. Patient receive either complete response, partial response, stable disease, progression of the disease. Treatment response will be assessed by treating physicians. Response will be compared between the two groups.
1 secondary outcome
Overall survival
Time frame: 4 years
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 12 May 2023.
- Individual participant dataSharing planned: No. IPD will not be shared with unauthorized persons. Anonymized data will only be exchanged between study coordinators and the analysis team.
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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.
Oliver A. Cornely, Prof. principal investigator
University Hospital of Cologne, Germany
Paul E. Verweij, Prof. principal investigator
Radboud University Nijmegen Medical Center, The Netherlands
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Aspergillosis, run by University Hospital of Cologne at 2 sites in 2 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 4 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: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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?
Treatment response to antifungal therapy in patients with an invasive Aspergillosis caused by an azole resistant pathogen. (time frame: Change from diagnosis at day 14, 28, 42 and 84 and throughout study completion). 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 12 May 2023.