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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Immunodeficiency and Suspected Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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No study treatment

Blood sampling / Body fluid sampling

Intervention Type 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...

Interventions

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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...

Intervention Type PROCEDURE

Eligibility Criteria

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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

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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No