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

Completed

• Conditions: Immunodeficiency and Suspected Infection
• Interventions: Procedure: Blood sampling / Body fluid sampling

• Registration Number: NCT02007642
• Lead Sponsor: Pathoquest

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-10
• Study Start: 2013-10
• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No study treatment	Blood sampling / Body fluid sampling	-

Primary Outcome Measures

Name	Time	Method
Identification of pathogens responsible for the infection	1 year	The primary outcome will assess the number of diagnostics obtained by the PATHOQUEST method and classic diagnostic approach.

Secondary Outcome Measures

Name	Time	Method
Delay of obtention of diagnostic	1 year	The delay of obtention of results will be compared to determine which approach allows an earlier diagnosis.
Economic impact of the PATHOQUEST method	1 year	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.

Trial Locations

Locations (2)

Hopital Necker - Enfants malades; 🇫🇷 Paris, Ile de France, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France