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.

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Key information

Conditions

Invasive Aspergillosis

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne, Cologne, North Rhine-Westphalia, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Registry

Other

There is no intervention.

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Collaborators

Radboud University Medical Center

Registry information

Official study title

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

Acronym: CLARITY

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Jul 18, 2017
Registry last updated: May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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