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| Name | Class |
|---|---|
| Imagine Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No study treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling / Body fluid sampling | Procedure | 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... |
| 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 |
| 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. |
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Summary of inclusion criteria:
Primary or secondary immunodeficiencies defined by
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:
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Immunocompromised patients hospitalized for a suspected infectious disease
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| Name | Affiliation | Role |
|---|---|---|
| Marc Lecuit, Pr | marc.lecuit@nck.aphp.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | 75015 | France | |||
| Hopital Necker - Enfants malades |
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DNA sample by patient
|
| 1 year |
| Paris |
| Île-de-France Region |
| 75015 |
| France |
| ID | Term |
|---|---|
| D007153 | Immunologic Deficiency Syndromes |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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