NCT03004092

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.9 years

First QC Date

December 21, 2016

Last Update Submit

July 2, 2024

Conditions

Aspergillosis Invasive

Keywords

bis(methylthio)gliotoxinlateral flow deviceJF5GalactomannanInvasive aspergillosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of serum bmGT

    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.

    2 weeks

Secondary Outcomes (7)

  • Diagnostic accuracy of a combination of serum bmGT and serum GM

    2 weeks

  • Prognostic value of serum bmGT

    6 weeks

  • Prognostic value of serum bmGT kinetics

    6 weeks

  • Renal and hepatic influence on bmGT

    2 weeks

  • Compare bmGT-HPTLC to bmGT-LC/MS

    Same day

  • +2 more secondary outcomes

Study Arms (1)

Total cohort

EXPERIMENTAL
Procedure: blood sample

Interventions

blood samplePROCEDURE

Twice weekly blood sample, and at every outpatient visit

Total cohort

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 16y at start of study
  • One of the following diagnoses:
  • De novo, refractory or relapsed AML/MDS receiving intensive chemotherapy
  • De novo, refractory or relapsed ALL/T-lymphoblastic lymphoma receiving intensive chemotherapy
  • Aplastic anemia requiring ATG therapy
  • Any patient admitted for either autologous or allogeneic hematopoietic stem cell transplantation
  • Written informed consent obtained from the patient

You may not qualify if:

  • Directed treatment for possible, probable, or proven invasive aspergillosis, at moment of screening, or with end of treatment \< 6 weeks at screening, or no complete response according to EORTC/MSG criteria, or complete response achieved \< 6 weeks at time of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (6)

  • Pfeiffer CD, Fine JP, Safdar N. Diagnosis of invasive aspergillosis using a galactomannan assay: a meta-analysis. Clin Infect Dis. 2006 May 15;42(10):1417-27. doi: 10.1086/503427. Epub 2006 Apr 14.

    PMID: 16619154BACKGROUND

  • Lewis RE, Wiederhold NP, Chi J, Han XY, Komanduri KV, Kontoyiannis DP, Prince RA. Detection of gliotoxin in experimental and human aspergillosis. Infect Immun. 2005 Jan;73(1):635-7. doi: 10.1128/IAI.73.1.635-637.2005.

    PMID: 15618207BACKGROUND

  • Domingo MP, Colmenarejo C, Martinez-Lostao L, Mullbacher A, Jarne C, Revillo MJ, Delgado P, Roc L, Meis JF, Rezusta A, Pardo J, Galvez EM. Bis(methyl)gliotoxin proves to be a more stable and reliable marker for invasive aspergillosis than gliotoxin and suitable for use in diagnosis. Diagn Microbiol Infect Dis. 2012 May;73(1):57-64. doi: 10.1016/j.diagmicrobio.2012.01.012. Epub 2012 Apr 4.

    PMID: 22480566BACKGROUND

  • Vidal-Garcia M, Domingo MP, De Rueda B, Roc L, Delgado MP, Revillo MJ, Pardo J, Galvez EM, Rezusta A. Clinical validity of bis(methylthio)gliotoxin for the diagnosis of invasive aspergillosis. Appl Microbiol Biotechnol. 2016 Mar;100(5):2327-34. doi: 10.1007/s00253-015-7209-6. Epub 2015 Dec 17.

    PMID: 26678078BACKGROUND

  • Thornton CR. Development of an immunochromatographic lateral-flow device for rapid serodiagnosis of invasive aspergillosis. Clin Vaccine Immunol. 2008 Jul;15(7):1095-105. doi: 10.1128/CVI.00068-08. Epub 2008 May 7.

    PMID: 18463222BACKGROUND

  • Mercier T, Guldentops E, Lagrou K, Maertens J. Prospective Evaluation of the Turbidimetric beta-D-Glucan Assay and 2 Lateral Flow Assays on Serum in Invasive Aspergillosis. Clin Infect Dis. 2021 May 4;72(9):1577-1584. doi: 10.1093/cid/ciaa295.

    PMID: 32188971DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 28, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

BE(1)