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Completed

NCT Number: NCT02007642

Evaluation of High Throughput Sequencing for Screening 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.

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Key information

Conditions

Immunodeficiency and Suspected Infection Immune System Diseases Immunologic Deficiency Syndromes

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Necker - Enfants malades, Paris, Île-de-France Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Summary of inclusion criteria:

  • 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
  • Infection suspicion
  • Microbiological investigation
  • Adult or child above 1 year
  • Hospitalization at Necker-Enfants malades hospital
  • Registration to Healthcare organism
  • ICF signature

Summary of exclusion criteria:

  • Obvious diagnosis following clinical examination
  • Participation in a clinical trial for a new drug
  • People under legal guardianship
  • People unable to fulfil the required medical follow-up

Treatment and study plan

Blood sampling / Body fluid sampling

Procedure

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...

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Pathoquest

Industry

Collaborators

  • Imagine Institute

Registry information

Official study title

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

Acronym: PATHOQUEST1

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2013
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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