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iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients (IDENTIFY)

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ClinicalTrials.gov Identifier: NCT03364257
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pathoquest

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

Condition or disease Intervention/treatment
Febrile Neutropenia Acute Leukemia Stem Cell Transplantation Infection Diagnostic Test: iDTECT Blood

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 97 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection
Actual Study Start Date : May 18, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever


Intervention Details:
  • Diagnostic Test: iDTECT Blood
    Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples


Primary Outcome Measures :
  1. Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion [ Time Frame: 7 months ]
    Sensitivity, specificity, negative predictive value, positive predictive value at inclusion


Secondary Outcome Measures :
  1. Antiobiotic use [ Time Frame: 9 months ]
    Type of antibiotic, duration of antibiotic course


Biospecimen Retention:   Samples With DNA
Whole blood and plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated with chemotherapy for Acute Leukaemia (AL) or Myelodysplastic Syndrome (MDS) or in the context of hematopoietic stem cell transplantation (HSCT), presenting a febrile neutropenic episode and suspected of infection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364257


Contacts
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Contact: Dangles +33687137695 christine.dangles@pathoquest.com

Locations
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France
Hospital Necker Recruiting
Paris, France
Contact: Blanche, Prof, MD         
Hospital Robert Debré Recruiting
Paris, France
Contact: Baruchel, Prof, MD         
Hospital Salpétrière Recruiting
Paris, France
Contact: Souchet, MD         
Hospital Trousseau Recruiting
Paris, France
Contact: Petit, Prof, MD         
Hosptial Saint Louis Recruiting
Paris, France
Contact: Le Goff, MD         
Principal Investigator: Socié, Prof, MD         
Principal Investigator: Thieblemont, Prof, MD         
Principal Investigator: Raffoux, MD         
Sponsors and Collaborators
Pathoquest

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Responsible Party: Pathoquest
ClinicalTrials.gov Identifier: NCT03364257     History of Changes
Other Study ID Numbers: PTQ-02
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pathoquest:
metagenomic
infection
diagnosis

Additional relevant MeSH terms:
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Infection
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms