ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Aspergillosis"

Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis (MYCOGENIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03349931
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Société ADEMTECH SA
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Invasive Aspergillosis in Patients With Onco-haematological Diseases Diagnostic Test: DNA extraction and detection of Aspergillus fumigatus in serum samples

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 infections caused by other molds or bacteria on clinical and radiological grounds. Therefore, culture-based microbiological diagnosis is of primary importance but requires semi-invasive or invasive procedures, such as bronchoalveolar Lavage (BAL) or computed-tomography (CT)-guided needle biopsy.

Alternate diagnostic methods include the detection of biomarkers, such as fungal antigens (Aspergillus galactomannan [GM]) or DNA released by Aspergillus hyphae in host tissues. These biomarkers are well recognized as early IPA predictors Recently, several clinical evaluations to detect Aspergillus DNA, either in respiratory or in blood-based samples, have clearly shown the diagnostic value of this biomarker. In addition, methodological recommendations have been established for PCR protocols, and different standardized Aspergillus quantitative PCR (qPCR) kits have been commercialized. These recent advances show that PCR is now mature for routine use in clinical settings.

Another issue is the emergence of aspergillosis due to azole-resistant isolates. Acquired azole resistance in A. fumigatus has been reported since 1997 and has emerged in many countries, particularly in Europe, as well as on other continents. In some instances, acquired resistance may be driven by antifungal selection in patients receiving long-term therapy. Nevertheless, it seems that many azole-resistant strains originated in the environment due to selection by azole fungicides used in agriculture. Azole resistance in A. fumigatus is associated mainly with mutations in the cyp51A gene, and among several mutations described, the most frequent is the mutation comprising a 34-bp tandem repeat (TR34) and the L98H alteration. Since azoles are the recommended first-line treatment for IPA, the emergence of azole resistance is worrisome and has been shown to be associated with an increased rate of clinical failure. For these reasons, routine antifungal susceptibility testing of clinical isolates has been recommended recently. Nevertheless, isolates are not always retrieved in culture, particularly for patients with hematological malignancies. Therefore, molecular detection of resistance may be a major advance for the management of patients with invasive aspergillosis.

The aim of this study will be to validate the new MycoGENIE A. fumigatus real-time PCR kit and to evaluate its performance on clinical samples for the detection of A. fumigatus and its azole resistance. This multiplex assay detects DNA from the A. fumigatus species complex by targeting the multicopy 28S rRNA gene and specific TR34 and L98H mutations in the single-copy number cyp51A gene of A. fumigatus.

The study will be performed in hematological patients with high-risk of developping IA during the course of chemotherapy. In these patients, bi-weekly detection of GM is routinely performed in all centers in France. The PCR will be performed on the samples used for GM detection. DNA will be extracted according to the manufacturer's protocol, using the MycoGENIE kit for AutoMag solution. Real-time PCR for the detection of A. fumigatus DNA will be performed using the MycoGENIE A. fumigatus real-time PCR kit (Ademtech, Pessac, France).

AI will be defined as proven or probable aspergillosis, according to EORTC criteria.

For each patient, clinical data will be collected in each center. These data include: EORTC classification, type and duration of antifungal treatments, results of GM tests, results of mycological cultures, and results of PCR tests (positivity and Ct values). For each patient a case report form (CRF) will be filled and transfered to the investigating center for analysis. Sensitivity, specificity, PPV and NPV of the PCR test will be calculated.


Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis in Hematological Patients
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Group/Cohort Intervention/treatment
Hematological patients
Hematological patients at high risk for invasive aspergillosis
Diagnostic Test: DNA extraction and detection of Aspergillus fumigatus in serum samples
Performances diagnostic test 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).




Primary Outcome Measures :
  1. Performance of PCR for Aspergillosis diagnosis [ Time Frame: 6 months ]
    Determination of the performances (Sensitivity, specificity, PPV and NPV) of the kit


Secondary Outcome Measures :
  1. Detection of azole resistance [ Time Frame: 6 months ]
    Detection of TR34 and L98H mutations in the A. fumigatus single-copy number gene cyp51A.


Biospecimen Retention:   Samples Without DNA
Human sera (serum)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hematological patients at high risk for invasive aspergillosis, who can be classified according to EORTC criteria
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient < 18 years-old (minor)
  2. Informed consent not available
  3. Patient without affiliation to French social insurance
  4. Patient without biweekly screening for GM detection in serum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349931


Contacts
Contact: Marie-Elisabeth BOUGNOUX, MD, PhD +33 (0)1 44 49 25 45 marie-elisabeth.bougnoux@aphp.fr
Contact: PRISSILE BAKOUBOULA, PhD +33 (0)1 71 19 64 94 prissile.bakouboula@aphp.fr

Locations
France
CHU Bordeaux, Groupe hospitalier Recruiting
Bordeaux, France, 33000
Contact: Claire CALMETTES    +33 (0)5 57 65 65 11    claire.calmettes@chu-bordeaux.fr   
Principal Investigator: Claire CALMETTES, MD, PhD         
Principal Investigator: Isabelle ACCOCEBERRY, MD, PhD         
Principal Investigator: Noémie CORON, MD, PhD         
CHU de DIJON, Hôpital du bocage Recruiting
Dijon, France, 21000
Contact: Denis CAILLOT    +33 (0)3 80 29 36 45    denis.caillot@chu-dijon.fr   
Principal Investigator: Denis CAILLOT, MD, PhD         
Principal Investigator: Frederic DALLE, MD, PhD         
CHRU de Lille, Hôpital Claude Huriez Recruiting
Lille, France, 59000
Contact: Ibrahim Yakoub-Agha    +33 (0)3 20 44 55 51    i-yakoub-agha@chru-lille.fr   
Principal Investigator: Ibrahim Yakoub-Agha, MD, PhD         
Principal Investigator: Séverine Loridant, MD, PhD         
CHU de Nantes, Hôpital de Moncousu Recruiting
Nantes, France, 44000
Contact: Thomas GASTINNE    +33 (0)2 40 08 33 02    thomas.gastine@chu-nantes.fr   
Principal Investigator: Thomas GASTINNE, MD, PhD         
Principal Investigator: Patrice LE PAPE, MD, PhD         
Hôpital Necker - Enfants maladies (AP-HP) Recruiting
Paris, France, 75015
Contact: Marie-Elizabeth BOUGNOUX, MD, PhD    +33 (0)1 44 49 25 45    marie-elisabeth.bougnoux@aphp.fr   
Principal Investigator: Marie-Elisabeth BOUGNOUX, MD, PhD         
Principal Investigator: Felipe SUAREZ, MD, PhD         
CHU de RENNES, hôpital de Pontchaillou Recruiting
Rennes, France, 35000
Contact: Laure GOURSAUD    +33 (0)2 99 28 57 45    laure.goursaud@chu-rennes.fr   
Principal Investigator: Laure GOURSAUD, MD, PhD         
Principal Investigator: Jean-Pierre GANGNEUX, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société ADEMTECH SA
Investigators
Principal Investigator: Eric DANNAOUI, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Marie-Elisabeth BOUGNOUX, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03349931     History of Changes
Other Study ID Numbers: K-170102
2017-A01518-45 ( Registry Identifier: ID-RCB )
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Aspergillosis,
qPCR
allogenic haemopoietic stem-cell transplantation
leukemia

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases