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

Immunodeficiency and Suspected Infection Clinical Trial

— PATHOQUEST1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007642
• Other study ID #: PTQCT01-2013
• Status: Completed
• Phase: N/A
• First received: November 29, 2013
• Last updated: April 20, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2013
• Source: Pathoquest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Immunodeficiency and Suspected Infection
• Immunologic Deficiency Syndromes
• Infection

Intervention

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...

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris
France	Hopital Necker - Enfants malades	Paris	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Pathoquest	Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Delay of obtention of diagnostic	The delay of obtention of results will be compared to determine which approach allows an earlier diagnosis.	1 year	No
Secondary	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.	1 year	No