NCT02007642

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Pathoquest · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Immunodeficiency and Suspected Infection

Interventions

Type	Name	Description
PROCEDURE	Blood sampling / Body fluid sampling	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...

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-12-11
• Last updated: 2015-04-21

Locations

2 sites across 1 country: France