Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06075888

Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients

Led by Poitiers University Hospital · Updated on 2024-06-24

200

Participants Needed

5

Research Sites

52 weeks

Total Duration

On this page

Sponsors

P

Poitiers University Hospital

Lead Sponsor

N

Noscendo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Being treated for a solid tumor or hematological malignancy
  • Presenting with high-risk febrile neutropenia defined by a MASCC score of 21 or higher
  • Expected duration of neutropenia of 7 days or more with an absolute neutrophil count of 500/mm3 or less
  • Fever defined as temperature of 38.3C or higher, or 38C twice within one hour
  • Free from guardianship or subordination
  • Covered by social security or a third party
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Received antibiotic therapy in the 24 hours before enrollment, except prophylactic use of trimethoprim-sulfamethoxazole or penicillin G
  • Previous participation in this study
  • Persons under legal protection, minors, or persons deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding women who refuse or do not have effective contraception during the study period

AI-Screening

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Trial Site Locations

Total: 5 locations

1

C.H.U. d'Angers

Angers, France, 49933

Actively Recruiting

2

CHU de Brest

Brest, France, 29606

Actively Recruiting

3

C.H.U. de Limoges

Limoges, France

Not Yet Recruiting

4

C.H.U. de Poitiers

Poitiers, France, 86000

Actively Recruiting

5

C.H.U. de Tours

Tours, France, 37044

Actively Recruiting

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Research Team

M

Maxime PICHON

CONTACT

C

Corinne LORRAIN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

0

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