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

Starting soon

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

In brief

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).

Key facts

Study ID

NCT07603453

Run by

Assistance Publique - Hôpitaux de Paris

People needed

120

Starts

2026-06-01

Expected to finish

2028-09-01

Last updated by the study team

2026-05-22

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• No healthcare insurance

Where it is running

• Hôpital Necker - Enfants Malades — Paris, Île-de-France Region, France

Full record on ClinicalTrials.gov

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