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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03364257
Other study ID # PTQ-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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