Clinical Implications of Azole-Resistant Aspergillosis in Hematological Malignancy

NCT03221075 | Completed

• 1 other identifier: 17-024
• Study Type: observational
• Target: 203
• Locations: 2 countries
• Sites: 2

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.

Conditions

Invasive Aspergillosis

Keywords

Invasive Aspergillosis; Azole resistance; Aspergillus fumigatus; Efficacy of antifungal therapy; Patient registry

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from diagnosis at day 14, 28, 42 and 84 and throughout study completion

Secondary Outcomes (1)

• Overall survival

  4 years

Study Arms (1)

Invasive Aspergillosis

Other: Registry

Interventions

Registry OTHER

There is no intervention.

Invasive Aspergillosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases will be recruited worldwide.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Cologne: lead
• Radboud University Medical Center: collaborator

Study Sites (2)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

Radboud University Nijmegen Medical Center

Nijmegen, 6500, Netherlands

Location

MeSH Terms

Interventions

Registries

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Oliver A. Cornely, Prof.

  University Hospital of Cologne, Germany

  PRINCIPAL INVESTIGATOR

• Paul E. Verweij, Prof.

  Radboud University Nijmegen Medical Center, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: July 18, 2017
• Study Start: March 1, 2017
• Primary Completion: April 30, 2022
• Study Completion: October 25, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (1)