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Trial record 3 of 28 for:    Recruiting, Not yet recruiting, Available Studies | "Aspergillosis"

Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy (CLARITY)

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ClinicalTrials.gov Identifier: NCT03221075
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Prof. Dr. Oliver A. Cornely, University Hospital of Cologne

Brief 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 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.

Condition or disease Intervention/treatment
Invasive Aspergillosis Other: Registry

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 Type : Observational [Patient Registry]
Estimated Enrollment : 220 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: CLARITY - Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Group/Cohort Intervention/treatment
Invasive Aspergillosis Other: Registry
There is no intervention.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]
    Final outcome will be compared between the two groups in consideration of the type and state of underlying diseases and risk factors.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cases will be recruited worldwide.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Colonization only, without proof of invasive infection
  • Non-availability of the azole resistant isolate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221075


Contacts
Contact: Dorothee Arenz, Dr. +49 221 478 32786 dorothee.arenz@uk-koeln.de
Contact: Susann Bloßfeld +49 221 478 85523 susann.blossfeld@uk-koeln.de

Locations
Germany
University Hospital of Cologne Recruiting
Cologne, NRW, Germany, 50931
Contact: Oliver A. Cornely, Prof.         
Netherlands
Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Netherlands, 6500
Contact: Paul E. Verweij, Prof.         
Sponsors and Collaborators
University Hospital of Cologne
Radboud University
Investigators
Principal Investigator: Oliver A. Cornely, Prof. University Hospital of Cologne, Germany
Principal Investigator: Paul E. Verweij, Prof. Radboud University Nijmegen Medical Center, The Netherlands

Responsible Party: Prof. Dr. Oliver A. Cornely, Prof., University Hospital of Cologne
ClinicalTrials.gov Identifier: NCT03221075     History of Changes
Other Study ID Numbers: 17-024
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with unauthorized persons. Anonymized data will only be exchanged between study coordinators and the analysis team.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Oliver A. Cornely, University Hospital of Cologne:
Invasive Aspergillosis
Azole resistance
Aspergillus fumigatus
Efficacy of antifungal therapy
Patient registry

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases