Status:

COMPLETED

Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

Société ADEMTECH SA

URC-CIC Paris Descartes Necker Cochin

Conditions:

Invasive Aspergillosis in Patients With Onco-haematological Diseases

Eligibility:

All Genders

18+ years

Brief Summary

The purpose of this study is to evaluate the performances of the real-time PCR ADEMTECH kit of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at high-risk for invas...

Detailed Description

Accurate diagnosis of invasive pulmonary aspergillosis (IPA) in patients at high risk of invasive fungal infection remains challenging due to difficulties in differentiating IPA from pulmonary infecti...

Eligibility Criteria

Inclusion

  • Adult Patients (≥ 18 years) hospitalized in onco hematologic unit or in hematopoietic stem cell transplantation (HSCT) unit
  • Patients with acute leukemia undergoing induction for AML, ALL, chimotherapy with neutopenia \>10 days or Patients undergoing allogeneic stem cell chemotherapy transplantation
  • Patients with biweekly screening for GM detection in serum

Exclusion

  • Patient \< 18 years-old (minor)
  • Informed consent not available
  • Patient without affiliation to French social insurance
  • Patient without biweekly screening for GM detection in serum

Key Trial Info

Start Date :

February 5 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 20 2020

Estimated Enrollment :

350 Patients enrolled

Trial Details

Trial ID

NCT03349931

Start Date

February 5 2018

End Date

January 20 2020

Last Update

November 20 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Hôpital Necker - Enfants maladies (AP-HP)

Paris, Paris, France, 75015

2

CHU Bordeaux, Groupe hospitalier

Bordeaux, France, 33000

3

CHU de DIJON, Hôpital du bocage

Dijon, France, 21000

4

CHRU de Lille, Hôpital Claude Huriez

Lille, France, 59000