NCT03004092

Novel Biomarkers for Invasive Aspergillosis

Terminated NA Last updated 2 July 2024

What this trial tests

NA trial testing blood sample in Aspergillosis Invasive in 226 participants. Terminated before completion.

Timeline

1 January 2017

Primary endpoint
1 December 2019

1 February 2020

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	226
Start date	1 January 2017
Primary completion	1 December 2019
Estimated completion	1 February 2020
Sites	1 location across Belgium

Drugs / interventions tested

• blood sample — full drug profile →

Conditions studied

• Aspergillosis Invasive — all drugs for Aspergillosis Invasive →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

16 and older, any sex, with Aspergillosis Invasive. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Diagnostic accuracy of serum bmGT
  Time frame: 2 weeks
  Determine the diagnostic accuracy (specificity, sensitivity predictive values, accuracy and other key diagnostic values) of serum bmGT in the diagnosis of invasive aspergillosis, using the revised EORTC criteria as gold standard.

Sponsor's own description

Diagnosis of invasive aspergillosis remains difficult, and is often based on a combination of patient characteristics, radiological and microbiological findings. To data, galactomannan (GM) is the only well-validated biomarker available. However, GM still has its shortcomings. There is therefore a need for new, complementary biomarkers. In this study, two of those tests, bis(methylthio)gliotoxin (bmGT) and a lateral flow device, will be validated in a hematological population, and compare it to GM.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective Evaluation of the Turbidimetric β-D-Glucan Assay and 2 Lateral Flow Assays on Serum in Invasive Aspergillosis.
   Mercier T, Guldentops E, Lagrou K, Maertens J. · · 2021 · cited 28× · PMID 32188971 · DOI 10.1093/cid/ciaa295
2. Blood Mucorales PCR to track down <i>Aspergillus</i> and Mucorales co-infections in at-risk hematology patients: A case-control study.
   Aerts R, Bevers S, Beuselinck K, Schauwvlieghe A, et al · · 2022 · cited 17× · PMID 36569194 · DOI 10.3389/fcimb.2022.1080921