Identifying pathogens in patients with febrile neutropenia using metagenomic sequencing
Evaluation of the Diagnostic Performance of the DISQVER® Metagenomic Sequencing Tool for the Identification of Pathogens in Febrile Neutropenic Haemato-oncology Patients
NA · Poitiers University Hospital · NCT06075888
This study is testing a new way to quickly find infections in patients with febrile neutropenia, who are often at high risk due to their weakened immune systems from cancer treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital (other) |
| Drugs / interventions | Chemotherapy |
| Locations | 5 sites (Angers and 4 other locations) |
| Trial ID | NCT06075888 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to utilize metagenomic sequencing to identify pathogens in patients experiencing febrile neutropenia, a serious complication often seen in immunocompromised individuals undergoing treatment for hematological malignancies. The study focuses on patients who present with high-risk febrile neutropenia, defined by specific clinical criteria, and seeks to improve the speed and accuracy of pathogen identification. By employing advanced diagnostic techniques, the trial hopes to enhance treatment protocols and reduce the risk of severe complications associated with infections in these vulnerable patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are being treated for solid tumors or hematological malignancies and present with high-risk febrile neutropenia.
Not a fit: Patients who have received antibiotic therapy within 24 hours prior to enrollment or those with enhanced protection, such as minors or individuals deprived of their liberty, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate identification of infections, improving patient outcomes and reducing mortality rates.
How similar studies have performed: Other studies utilizing metagenomic sequencing for pathogen identification in similar patient populations have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Angers and 4 other locations
- C.H.U. d'Angers — Angers, France (RECRUITING)
- CHU de Brest — Brest, France (RECRUITING)
- C.H.U. de Limoges — Limoges, France (NOT_YET_RECRUITING)
- C.H.U. de Poitiers — Poitiers, France (RECRUITING)
- C.H.U. de Tours — Tours, France (RECRUITING)
Study contacts
- Study coordinator: Maxime PICHON
- Email: maxime.pichon@chu-poitiers.fr
- Phone: +33 5.49.44.41.43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Immunodepressed Patients, Neutropenia, Fever, Bacteremia, Viremia, Fungemia, Antibiotic