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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 occurs in approximately 10% to 15% of patients treated for solid tumours and up to 100% of patients treated for haematological malignancies, particularly after bone marrow and/or haematopoietic stem cell transplantation. In 25% to 30% of cases, NF leads to serious complications. The vast majority of NF cases are caused by microbial infections (bacteria, viruses, fungi, parasites, etc.), which can progress to severe sepsis or septic shock if appropriate treatment is not initiated rapidly (introduction of anti-infective molecules and implementation of associated procedures). If no pathogen is identified during the management of the most severe patients, the prognosis is poor, with a mortality rate of 10%. The performance of diagnostic strategies is therefore an important factor in improving the prognosis of these patients. To date, the reference diagnosis of microorganisms is based on blood cultures, blood Polymerase Chain Reaction (PCR), β-D-glucan and aspergillosis serology. Identifying the pathogens responsible for NF from a blood sample without an a priori hypothesis and in an optimised timeframe could allow earlier treatment of high-risk NF with implications for management (possible modification of antimicrobial and/or immunosuppressive treatment). The aim of this study is to evaluate the performance of the mNGS-DISQVER® tool in diagnosing pathogenic microorganisms from blood samples collected from patients being managed for high-risk NF.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
C.H.U. d'Angers
RECRUITING
Angers
CHU de Brest
RECRUITING
Brest
C.H.U. de Limoges
NOT_YET_RECRUITING
Limoges
C.H.U. de Poitiers
RECRUITING
Poitiers
C.H.U. de Tours
RECRUITING
Tours
Contact Information
Primary
Maxime PICHON
maxime.pichon@chu-poitiers.fr
+33 5.49.44.41.43
Backup
Corinne LORRAIN
corinne.lorrain@chu-poitiers.fr
+33 5.49.44.39.30
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2025-01-12
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Collaborators: Noscendo
Leads: Poitiers University Hospital

This content was sourced from clinicaltrials.gov