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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-18

Study Completion Date

2019-05-31

Brief Summary

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Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

Detailed Description

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Febrile neutropenic patients suspected of sepsis will follow the conventional infectious diagnosis work-up over the entire observation period, and will be tested in addition with iDTECT Blood on Study Day 1.

Conditions

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Febrile Neutropenia Acute Leukemia Stem Cell Transplantation Infection

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Age \> 5 years and weight \> 16 Kg
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

1. Known HIV infection or AIDS diagnosis
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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pathoquest

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Necker

Paris, , France

Site Status RECRUITING

Hospital Robert Debré

Paris, , France

Site Status RECRUITING

Hospital Salpétrière

Paris, , France

Site Status RECRUITING

Hospital Trousseau

Paris, , France

Site Status RECRUITING

Hosptial Saint Louis

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dangles

Role: CONTACT

+33687137695

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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