Evaluation of High Throughput Sequencing for Screening of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.

Study Overview
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Brief Summary
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The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease. The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach. The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.

Official Title
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Performance Assessment of High Throughput Sequencing for the Detection of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.

Conditions
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Immunodeficiency and Suspected Infection

Intervention / Treatment
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* Procedure: Blood sampling / Body fluid sampling


Participation Criteria
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Eligibility Criteria
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Summary of inclusion criteria: Primary or secondary immunodeficiencies defined by Solid organ transplantation and immunosuppressive drug Recent chemotherapy Hematopoïetic Stem Cells transplantation Primary immune deficiency Auto-immune disease HIV infection Infection suspicion Microbiological investigation Adult or child above 1 year Hospitalization at Necker-Enfants malades hospital Registration to Healthcare organism ICF signature Summary of exclusion criteria: Obvious diagnosis following clinical examination Participation in a clinical trial for a new drug People under legal guardianship People unable to fulfil the required medical follow-up

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No study treatment<br> | Procedure: Blood sampling / Body fluid sampling<br>* During the hospitalization of the patient, when a sampling is done for classic follow-up and diagnosis, additionnal blood sampling will be done, for the PATHOQUEST method. Other body fluids might be taken (if the sampling is done for the classic follow-up), such as cerebrospinal fluid, ascite...<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of pathogens responsible for the infection | The primary outcome will assess the number of diagnostics obtained by the PATHOQUEST method and classic diagnostic approach. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay of obtention of diagnostic | The delay of obtention of results will be compared to determine which approach allows an earlier diagnosis. | 1 year | 
| Economic impact of the PATHOQUEST method | Comparison of the cost of the classic diagnostic approach and PATHOQUEST method, including cost of the hospital stay, microbiological tests performed, empirical anti-infectious drugs prescribed. | 1 year |