Status:
RECRUITING
Metagenomic Sequencing for the Identification of Pathogens in Febrile Neutropenic Patients
Lead Sponsor:
Poitiers University Hospital
Collaborating Sponsors:
Noscendo
Conditions:
Immunodepressed Patients (Hemato-oncology)
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 num...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 12 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06075888
Start Date
January 12 2024
End Date
January 12 2025
Last Update
June 24 2024
Active Locations (5)
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1
C.H.U. d'Angers
Angers, France, 49933
2
CHU de Brest
Brest, France, 29606
3
C.H.U. de Limoges
Limoges, France
4
C.H.U. de Poitiers
Poitiers, France, 86000