NCT02851680

Brief Summary

In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
476

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
Last Updated

August 3, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

July 28, 2016

Last Update Submit

August 2, 2016

Conditions

Invasive Fungal Infections

Outcome Measures

Primary Outcomes (1)

  • Comparison of the results of the 1-3 ß D glucan serum assay obtained with the Fungitell® test and the test currently used (in terms of specificity, sensitivity, negative predictive value and positive predictive value

    8 to 10 assays over 4 to 5 weeks of hospitalization

Study Arms (2)

Fongitell test

EXPERIMENTAL
Biological: blood samples

serum galactomannan

ACTIVE COMPARATOR
Biological: blood samples

Interventions

blood samplesBIOLOGICAL
Fongitell testserum galactomannan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have been informed about the study
  • Patients over 18 years
  • patients with acute myeloblastic leukaemia (AML) or lymphoblastic leukaemia (ALL) who have undergone cytotoxic chemotherapy with curative intent

You may not qualify if:

  • Adults under guardianship
  • Patients without national health insurance cover
  • Pregnant or breast-feeding women
  • allografts and autografts of Haematopoietic Stem Cells (HSC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 2, 2016

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Last Updated

August 3, 2016

Record last verified: 2016-06

Locations

FR(1)