Can a drug prevent gut problems and pneumonia in Brain-Injured patients?
NCT ID NCT05008926
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 370 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
10 sites. The list below names each one and where it is.
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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.
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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
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CHU Bordeaux
Bordeaux, 33000, France
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CHU Brest
Brest, 29609, France
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CHU Nantes
Nantes, 44093, France
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CHU Tours - Hôpital BRETONNEAU
Tours, 37000, France
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CHU Tours - Hôpital TROUSSEAU
Tours, 37170, France
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CHU de Bordeaux - Réanimation chirurgicale
Bordeaux, France, 33000, France
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CHU de Lille
Lille, 59000, France
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CHU de Montpellier
Montpellier, 34295, France
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CHU de Strasbourg
Strasbourg, 67098, France
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Hôpital La Pitié Salpétrière (APHP)
Paris, 75013, France
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Other studies related to the condition(s) this trial covers.
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- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Can a simple device keep breathing tubes sealed and cut pneumonia risk?
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury