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Could a stool sample replace a spinal tap? new study tests Non-Invasive infection detection

NCT ID NCT07603453

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test whether analyzing stool and urine samples using a technique called metagenomics can find infections in people with weakened immune systems (due to HIV, chemotherapy, or immunosuppressive drugs). Currently, doctors often need to take invasive samples like blood, spinal fluid, or tissue biopsies to find the cause of an infection. If stool and urine work as well, it could make diagnosis easier and safer. The study will enroll 120 participants and compare results from non-invasive samples with those from standard invasive tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metagenomic sequencing (mNGS) of stool and urine samples
What this could lead to
If successful, this could allow doctors to diagnose infections in immunocompromised patients using simple stool or urine samples instead of invasive procedures like spinal taps or tissue biopsies.
What could go wrong
This is an early-stage study with only 120 participants, so results may not apply to all patients. The technique may not detect all pathogens, and false positives or negatives are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric or adult patient with a primary or secondary immune deficiency

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease inborn error of immunity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary or secondary immune deficiency including immunosuppressive therapy, chemotherapy, HIV infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Necker - Enfants Malades

    Paris, Île-de-France Region, 75015, France

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