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

Infection Clinical Trial

— IDENTIFY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03364257
• Other study ID #: PTQ-02
• Status: Recruiting
• Start date: May 18, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2018
• Source: Pathoquest
• Contact: Dangles
• Phone: +33687137695
• Email: christine.dangles[@]pathoquest.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: May 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Hospital Necker	Paris
France	Hospital Robert Debré	Paris
France	Hospital Salpétrière	Paris
France	Hospital Trousseau	Paris
France	Hosptial Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pathoquest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 months
Secondary	Antiobiotic use	Type of antibiotic, duration of antibiotic course	9 months