Evaluation of High Throughput Sequencing for Screening of Pathogens in Immunocompromised Patients With Suspected Infectious Disease. (PATHOQUEST1)

Pathoquest

Status: Completed

Conditions: Immunodeficiency and Suspected Infection

Treatments: Procedure: Blood sampling / Body fluid sampling

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02007642

PTQCT01-2013

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

250 participants in 1 patient group

No study treatment

Treatment:

Procedure: Blood sampling / Body fluid sampling