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Can a drug prevent gut problems and pneumonia in Brain-Injured patients?

NCT ID NCT05008926

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
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether naloxegol, a drug that blocks opioid effects in the gut, can prevent constipation and pneumonia in brain-injured patients in the ICU. These patients often receive opioids for sedation, which can slow digestion and lead to serious complications. The trial aims to see if giving naloxegol early can reduce these risks.

What this could mean

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

Active substance
Naloxegol
What this could lead to
If it works, this could point toward a way to prevent constipation and pneumonia in brain-injured patients on opioids in the ICU.
What could go wrong
The trial is currently suspended, so results are uncertain. It is also a prevention study in a specific ICU population, so benefits may not apply broadly.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 370 people

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

Started

Mar 2022

Expected to finish

Apr 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.

Ages

18 years and older

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: 1. Age ≥ to 18 years old 2. Admission to intensive care unit for traumatic brain injury or subarachnoid hemorrhage without other life-threatening injury 3. Patients under sedation with administration of opiate-agonists, μ receptor agonists (Sufentanil, Fentanyl, Remifentanil, Morphine) for less than 24 hours 4. Expected duration of invasive mechanical ventilation and sedation of 48 hours or more 5. Intracranial pressure monitoring 6. Enteral feeding by oro / nasogastric tube 7. Affiliated or beneficiary of the French social security system Exclusion Criteria: 1. Patient who received opioids for more than 24 hours 2. Patient with refractory intracranial hypertension at the time of inclusion: intracranial hypertension requiring therapy other than analgo-sedation (thiopental, targeted temperature management, decompressive craniectomy) 3. Acute or chronic renal failure with creatinine clearance \<60ml / min 4. Known or suspected acute gastrointestinal obstruction 5. Risk of digestive perforation: * history of peptic ulcer * Crohn's disease * Ogilvie syndrome * acute diverticulitis * infiltrating gastrointestinal tumor * recurrent or advanced ovarian cancer * peritoneal metastasis * recent abdominal trauma with risk of digestive perforation 6. Concomitant treatment with a strong or moderate inhibitory effect of CYP 3A4 (For example: clarithromycin, ketaconazole, itraconazole, telithromycin, ritonavir, indinavir, saquinavir) or with a strong inducing effect (carbamazepin, rifampicin, millepertuis) 7. Concomitant treatment with vascular endothelial growth factor (VEGF) inhibitor 8. Allergy to Naloxegol or one of its excipients 9. Recent history of myocardial infarction within the past 6 months, symptomatic congestive cardiovascular disease, QT ≥ 500 msec 10. Patient with a medical decision for rapid palliative care 11. Pregnancy and / or breastfeeding 12. Child Pugh C stage cirrhosis 13. Patient under legal protection or deprived of liberty 14. Patient with another life-threatening injury 15. History of clinically important alterations of the blood-brain barrier: primary brain tumors, metastasis or other inflammatory pathologies in the CNS, active multiple sclerosis, Alzheimer's disease at an advanced stage.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • CHU Bordeaux

    Bordeaux, 33000, France

  • CHU Brest

    Brest, 29609, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU Tours - Hôpital BRETONNEAU

    Tours, 37000, France

  • CHU Tours - Hôpital TROUSSEAU

    Tours, 37170, France

  • CHU de Bordeaux - Réanimation chirurgicale

    Bordeaux, France, 33000, France

  • CHU de Lille

    Lille, 59000, France

  • CHU de Montpellier

    Montpellier, 34295, France

  • CHU de Strasbourg

    Strasbourg, 67098, France

  • Hôpital La Pitié Salpétrière (APHP)

    Paris, 75013, France

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