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RECRUITING
NCT06075888
NA

Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients

Sponsor: Poitiers University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-01-12

Completion Date

2025-01-12

Last Updated

2024-06-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Metagenomic diagnosis (mNGS, DISQVER)

Blood sample taken for metagenomic sequencing at inclusion visit.

Locations (5)

C.H.U. d'Angers

Angers, France

CHU de Brest

Brest, France

C.H.U. de Limoges

Limoges, France

C.H.U. de Poitiers

Poitiers, France

C.H.U. de Tours

Tours, France