ClinicalTrials.gg
Status unknownNCT03364257IDENTIFYUpdated Mar 21, 2019

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

An observational study in Febrile Neutropenia, Acute Leukemia and Stem Cell Transplantation, sponsored by Pathoquest. Status unknown at 5 sites in France. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by Pathoquest · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
97
Ages
5 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Febrile Neutropenia with a site in France — 1 open to participants now, 1 under way, 1 of them phase 3. Febrile Neutropenia · France.

Planned enrollment
8th of 10
97 · median 122
Started
2018
with 1 other
Observational
10 of 16
none open now
Registered
9th of 16
by date
Lead sponsor
1 of 16
Pathoquest

Among the 16 studies in Febrile Neutropenia with a site in France, this one is the 8th largest by planned enrollment of the 10 observational ones, is one of 2 that started in 2018, is one of 10 observational ones, and was the 9th registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

Observationalthis study10 · 0 open
No phase3 · 0 open
Phase 32 · 1 open
Phase 41 · 0 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2018.

Size and results

Median enrollment 484 across the 6 interventional studies, 122 across the 10 observational. Of the 14 that completed or were terminated, 2 (14%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 16 studies in Febrile Neutropenia with a site in France, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • Febrile Neutropenia
  • Acute Leukemia
  • Stem Cell Transplantation
  • Infection

Keywords

  • metagenomic
  • infection
  • diagnosis
04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 5 years and weight > 16 Kg
  2. Patients having signed the written study 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 ( \< 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

Exclusion Criteria:

  1. Known 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
97 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testiDTECT Blood

    Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples

06

What researchers measure

Primary outcomes

  1. Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion

    Sensitivity, specificity, negative predictive value, positive predictive value at inclusion

    Time frame: 7 months

Secondary outcomes

  1. Antiobiotic use

    Type of antibiotic, duration of antibiotic course

    Time frame: 9 months

07

Study locations

5 of 5 sites recruiting
  • Hospital Necker
    Paris, France
    Recruiting
    • Blanche, Prof, MD · Contact
  • Hospital Robert Debré
    Paris, France
    Recruiting
    • Baruchel, Prof, MD · Contact
  • Hospital Salpétrière
    Paris, France
    Recruiting
    • Souchet, MD · Contact
  • Hospital Trousseau
    Paris, France
    Recruiting
    • Petit, Prof, MD · Contact
  • Hosptial Saint Louis
    Paris, France
    Recruiting
    • Le Goff, MD · Contact
    • Socié, Prof, MD · Principal investigator
    • Thieblemont, Prof, MD · Principal investigator
    • Raffoux, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2018 (actual). Primary completion is estimated for Apr 2019, 11 months after the start.

Of 21 observational studies under Febrile Neutropenia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2017
First posted
Dec 6, 2017
StartActual
May 18, 2018
Primary completionEst.
Apr 30, 2019
CompletionEst.
May 31, 2019
Last update
Mar 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03364257
Lead sponsor
Pathoquest
Responsible party
Sponsor
First posted
Dec 6, 2017
Start date
May 18, 2018
Primary completion
Apr 30, 2019 (estimated)
Completion
May 31, 2019 (estimated)
Last update
Mar 21, 2019

Study contacts

Dangles
Contact
christine.dangles@pathoquest.com
+33687137695

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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