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

N/ACompletedNCT02007642

Pathoquest250 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Immunodeficiency and Suspected Infection

Interventions

Blood sampling / Body fluid samplingPROCEDURE

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...

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

Summary of inclusion criteria: 1. 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 2. Infection suspicion 3. Microbiological investigation 4. Adult or child above 1 year 5. Hospitalization at Necker-Enfants malades hospital 6. Registration to Healthcare organism 7. ICF signature Summary of exclusion criteria: 1. Obvious diagnosis following clinical examination 2. Participation in a clinical trial for a new drug 3. People under legal guardianship 4. People unable to fulfil the required medical follow-up

Locations (2)

Hôpital Européen Georges Pompidou

Paris, France

Hopital Necker - Enfants malades

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Delay of obtention of diagnostic

The delay of obtention of results will be compared to determine which approach allows an earlier diagnosis.

Time frame: 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.

Time frame: 1 year