Febrile NeutropeniaIDENTIFYNCT03364257
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
An observational study of Febrile Neutropenia and Acute Leukemia, run by Pathoquest at 5 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Febrile Neutropenia, Acute Leukemia, Stem Cell Transplantation
- What is being tested?
- iDTECT Blood
- How many people
- 97 participants
- Where
- 5 sitesFrance
- Study dates
- 18 May 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Age > 5 years and weight > 16 Kg
- 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
- 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
- Febrile episode (oral temperature > 38.3°C once, or 2 measures > 38.0°C taken 2h apart).
Who cannot join
- Known HIV infection or AIDS diagnosis
- Already microbiologically confirmed infection
- Patient status preventing the study test to be performed
- Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Hospital Necker
Paris
Blanche, Prof, MD
- Recruiting
Hospital Robert Debré
Paris
Baruchel, Prof, MD
- Recruiting
Hospital Salpétrière
Paris
Souchet, MD
- Recruiting
Hospital Trousseau
Paris
Petit, Prof, MD
- Recruiting
Hosptial Saint Louis
Paris
Le Goff, MD
Socié, Prof, MD
About this study
Official title: 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
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.
- Being tested
- iDTECT Blood
- Keywords
- metagenomic, infection, diagnosis
- Medical subject headings
- Febrile Neutropenia, Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDTECT BloodDiagnostic test
Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 months
Secondary outcomes (1)
Antiobiotic use
Type of antibiotic, duration of antibiotic course
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start18 May 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pathoquest
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364257
- Sponsor's protocol ID
- PTQ-02
- Acronym
- IDENTIFY
- Status last verified
- Dec 2018
- First submitted
- 28 Nov 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection
- ClinicalTrials.gov ID
- NCT03364257
- Acronym / sponsor ID
- IDENTIFY / PTQ-02
- Keywords
- metagenomic, infection, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- PathoquestIndustry (pharma, biotech, devices)
- Study start
- 18 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age > 5 years and weight > 16 Kg
- 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
- 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
- Febrile episode (oral temperature > 38.3°C once, or 2 measures > 38.0°C taken 2h apart).
Key exclusion criteria (4 listed)
- Known HIV infection or AIDS diagnosis
- Already microbiologically confirmed infection
- Patient status preventing the study test to be performed
- Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iDTECT BloodNext generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Antiobiotic use
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia and Acute Leukemia, run by Pathoquest at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dangles (+33687137695, christine.dangles@pathoquest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.