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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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