Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03221075 |
| Other study ID # |
17-024 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2017 |
| Est. completion date |
October 25, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
University Hospital of Cologne |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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 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.
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).
