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Clinical Trials in France / NCT07603453
Starting soon Observational

Performance of Clinical Metagenomics in Stool and Urine Samples for Unexplained Diseases Diagnostic and Emerging Diseases Surveillance in Immunocompromised Patients

NCT07603453 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2026-06-01
Last updated
2026-05-22

Condition(s) studied

Primary or Secondary Immune Deficiency Including Immunosuppressive Therapy, Chemotherapy, HIV Infection

Investigational drug(s) / intervention(s)

Metagenomics

Metagenomics: The intervention aims to increase pathogen detection of mNGS with the addition of non-invasive samples compared with invasive sampling alone

Study summary

The study is based on the hypothesis that the concomitant use of mNGS in non-invasive samples (stool, urine) could improve the rate of detected pathogens in immunodeficient patients compared with mNGS performed in an invasive reference sample alone (blood, CSF, broncho-alveolar lavage fluid (BAL), tissue).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pediatric or adult patient with a primary or secondary immune deficiency (including immunosuppressive therapy, chemotherapy, HIV infection). * mNGS prescription on tissue, CSF, BAL and/or blood to identify the causative pathogen in patient with symptoms or biological signs compatible with an infection as per investigator's judgment (e.g., fever, leukocytosis, increased CRP level) * Non opposition of the participant (or parent(s)/ legal guardian(s) of infant participant) Exclusion Criteria: * No healthcare insurance

Primary outcome measure(s)

  • Detection of a "causative" or "possibly causative" pathogens by mNGS in Non-Invasive (stool and/or urine) and invasive samples (blood, CSF, BAL and/or tissue) — 14 days
    * Possibly causative pathogen: microorganism associated with the symptoms in literature but without formal proof of causality. * Causative pathogen: known pathogen detected and typical associated symptoms.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker - Enfants Malades Paris Île-de-France Region

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07603453 on ClinicalTrials.gov ↗ ← All trials in France