iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
NCT ID: NCT03364257
Last Updated: 2019-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
97 participants
OBSERVATIONAL
2018-05-18
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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iDTECT Blood
Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples
Eligibility Criteria
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Inclusion Criteria
2. Patients having signed the written study informed consent form (ICF) prior to any study-mandated procedure. For children/adolescents: ICF obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed
3. Patient presenting severe neutropenia (absolute neutrophil count \< 0.5 Giga/L) anticipated to be long lasting (\> 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (AML or ALL) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation
4. Febrile episode (oral temperature \> 38.3°C once, or 2 measures \> 38.0°C taken 2h apart).
Exclusion Criteria
2. Already microbiologically confirmed infection
3. Patient status preventing the study test to be performed
4. Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation
5 Years
ALL
No
Sponsors
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Pathoquest
INDUSTRY
Responsible Party
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Locations
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Hospital Necker
Paris, , France
Hospital Robert Debré
Paris, , France
Hospital Salpétrière
Paris, , France
Hospital Trousseau
Paris, , France
Hosptial Saint Louis
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Blanche, Prof, MD
Role: primary
Baruchel, Prof, MD
Role: primary
Souchet, MD
Role: primary
Petit, Prof, MD
Role: primary
Le Goff, MD
Role: primary
Other Identifiers
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PTQ-02
Identifier Type: -
Identifier Source: org_study_id
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