CompletedNot Applicable

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

France350 participantsStarted 2018-02-05

Plain-language 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 invasive aspergillosis (IA). DNA detection will be associated with detection of TR34/L98H mutations in cyp51A gene, which confer azole resistance.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Performance of PCR for Aspergillosis diagnosis

Timeframe: 6 months

Trial details

NCT IDNCT03349931

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01-20

View on ClinicalTrials.gov More Invasive Aspergillosis in Patients With Onco-haematological Diseases trials