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

April 20, 2015 updated by: Pathoquest

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
    • Ile de France
      • Paris, Ile de France, France, 75015
        • Hôpital Necker - Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Immunocompromised patients hospitalized for a suspected infectious disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No study treatment
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...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of pathogens responsible for the infection
Time Frame: 1 year
The primary outcome will assess the number of diagnostics obtained by the PATHOQUEST method and classic diagnostic approach.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay of obtention of diagnostic
Time Frame: 1 year
The delay of obtention of results will be compared to determine which approach allows an earlier diagnosis.
1 year
Economic impact of the PATHOQUEST method
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pathoquest

Collaborators

Imagine Institute

Investigators

  • Principal Investigator: Marc Lecuit, Pr, marc.lecuit@nck.aphp.fr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTQCT01-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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