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

March 19, 2019 updated by: Pathoquest

National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Hospital Necker
        • Contact:
          • Blanche, Prof, MD
      • Paris, France
        • Recruiting
        • Hospital Robert Debre
        • Contact:
          • Baruchel, Prof, MD
      • Paris, France
        • Recruiting
        • Hospital Salpétrière
        • Contact:
          • Souchet, MD
      • Paris, France
        • Recruiting
        • Hospital Trousseau
        • Contact:
          • Petit, Prof, MD
      • Paris, France
        • Recruiting
        • Hosptial Saint Louis
        • Contact:
          • Le Goff, MD
        • Principal Investigator:
          • Socié, Prof, MD
        • Principal Investigator:
          • Thieblemont, Prof, MD
        • Principal Investigator:
          • Raffoux, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antiobiotic use
Time Frame: 9 months
Type of antibiotic, duration of antibiotic course
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pathoquest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2018

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 5, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTQ-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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