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Clinical Trial NCT06075888 (ADNEMIA) for Immunodepressed Patients (Hemato-oncology) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients (ADNEMIA) 200

Recruiting
Clinical Trial NCT06075888 (ADNEMIA) is an interventional study for Immunodepressed Patients (Hemato-oncology) that is recruiting. It started on 12 January 2024 with plans to enroll 200 participants. Led by Poitiers University Hospital, it is expected to complete by 12 January 2025. The latest data from ClinicalTrials.gov was last updated on 24 June 2024.
Brief Summary
The development of targeted therapies and intensive protocols in oncohaematology has improved the survival of patients with haematological malignancies. The increase in the number of patients treated and their life expectancy has been accompanied by an increase in the incidence of infectious complications secondary to the immunosuppression induced by these therapies.

Febrile neutropenia (NF) is a complication that o...

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Detailed Description

  1. Clinical context

    The development of targeted therapies and intensive protocols in oncohaematology has improved the survival of patients with haematological malignancies. The increase in the number of patients treated and their life expectancy has been accompanied by an increased incidence of infectious complications secondary to the immunosuppression induced by these therapies.

    Chemotherapy-induced febrile...

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Official Title

Evaluation of the Diagnostic Performance of the DISQVER® Metagenomic Sequencing Tool for the Identification of Pathogens in Febrile Neutropenic Haemato-oncology Patients

Conditions
Immunodepressed Patients (Hemato-oncology)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • ADNEMIA
NCT ID Number
NCT06075888
Start Date (Actual)
2024-01-12
Last Update Posted
2024-06-24
Completion Date (Estimated)
2025-01-12
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Neutropenia
Fever
Bacteremia
Viremia
Fungemia
Antibiotic
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
Metagenomic diagnosis (mNGS, DISQVER)
Blood sample taken for metagenomic sequencing at inclusion visit.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Performances (intrinsic diagnostic capabilities) of Metagenomic testing
Based on the microorganisms identified by the conventional work-up and the mNGS-DISQVER® tool, an adjudication committee consisting of a microbiologist, an infectiologist and a haematologist, independent of the study, will assess the presence of at least one pathogen requiring appropriate management. The interpretation of the conventional work-up and that provided by the mNGS-DISQVER® tool will be blinded. The intrinsic diagnostic capabilities will be assessed by the sensitivity/specificity of the new mNGS-DISQVER® test, with the classification resulting from the conventional work-up as the reference.
1 day
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Performances (extrinsic diagnostic capabilities) of Metagenomic testing
The Youden index, the positive and negative predictive values of the new mNGS-DISQVER® test (with conventional work-up as reference) and the proportions of concordant and discordant pairs between the new test and conventional work-up.
1 day
Clinical impact of Metagenomic testing on therapeutic choices
The differences between the percentages of patient management modalities (escalation, maintenance, de-escalation or discontinuation of anti-infective treatment) using the mNGS-DISQVER® tool versus the conventional work-up.
1 day
Use of Metagenomic testing during clinical patient's management
The mean time taken for conventional assessment, the prevalence of microorganisms diagnosed in routine care (independent of the adjudication committee) and the percentage distribution of anti-infective adjustments according to microorganisms diagnosed in routine care.
1 day
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patient
  • Age ≥18 years
  • Being treated for solid tumour or haematological malignancy
  • Presenting with high-risk febrile neutropenia (high-risk is defined by a Multinational Association for Supportive Care in Cancer (MASCC) score ≥ 21) with an expected duration of neutropenia ≥ 7 days. Neutropenia is defined as an absolute neutrophil count ≤ 500/mm3. Fever is defined as temperature ≥ 38.3°C or ≥ 38°C twice within 1 hour.
  • Free, without guardianship, tutelage or subordination;
  • covered by a social security scheme or by a third party;
  • have given informed consent to participate in the study.

  • Antibiotic therapy in the 24 hours prior to enrolment, with the exception of prophylactic use of trimethoprim-sulfamethoxazole (Cotrimoxazole) and penicillin G (Oracillin®).
  • Previous study participation
  • Patients with enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons in a health or social care institution, adults under legal protection;
  • Pregnant or lactating women of childbearing age (menopause must be documented) who refuse or do not have an effective method of contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device or surgical: tubal ligation, hysterectomy, total oophorectomy) for the duration of the study.
Poitiers University Hospital logoPoitiers University Hospital
Noscendo logoNoscendo
Study Central Contact
Contact: Maxime PICHON, +33 5.49.44.41.43, [email protected]
Contact: Corinne LORRAIN, +33 5.49.44.39.30, [email protected]
5 Study Locations in 1 Countries
C.H.U. d'Angers, Angers, 49933, France
CORENTIN ORVAIN, MD, Contact, +33241356451, [email protected]
Recruiting
CHU de Brest, Brest, 29606, France
ANNE-MARIE COUTURIER, MD, Contact, +33292020162, [email protected]
Recruiting
C.H.U. de Limoges, Limoges, France
TURLURE Pascal, MD, Contact, +33 5 55 05 88 62, [email protected]
Not yet recruiting
C.H.U. de Poitiers, Poitiers, 86000, France
NIELS MOYA, MD, Contact, +33549445643, [email protected]
Recruiting
C.H.U. de Tours, Tours, 37044, France
ALBAN VILATTE, MD, Contact, +33247477092, [email protected]
Recruiting