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Can a common steroid help trauma patients fight off infection?

NCT ID NCT00563303

Disease control Sponsor: Nantes University Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether hydrocortisone, a steroid the body makes naturally, helps severely injured patients who may not produce enough of it on their own. The trial enrolls about 150 people hospitalized after major trauma, all on breathing machines for at least two days. Half receive hydrocortisone for six days and half receive a saltwater placebo. The team tracks whether patients develop hospital-acquired pneumonia, other infections, organ failure, or die.

What this could mean

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

Active substance
hydrocortisone
What this could lead to
If it works, hydrocortisone could become a standard add-on for severely injured patients whose adrenal glands underperform, helping them fight off infections and avoid organ failure.
What could go wrong
This is a mid-stage trial in a very sick, hard-to-study population. Steroids can suppress the immune system, which might raise infection risk instead of lowering it, and results in trauma patients often do not carry over to other groups.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

150 people

The number who actually took part.

Start date

Nov 2006

Finished

Jul 2009

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

15 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: * Age superior of 15 years * Hospitalization in reanimation for polytraumatism (lesion of two organs with a vital risk) * SISS score more than 15 * Intubation for more than 48 hours. * Agreement of a family member * Patient with insurance Exclusion Criteria: * History of corticothérapies within 6 months * History of adrenocortical insufficiency. * Treatment by immunosuppressor * Immunodeficiency.

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Conditions

The condition(s) this trial relates to.

Multiple Trauma

As listed by the trial registrant

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

Polytraumatism

Contacts and locations

Locations

  • CH La Roche Sur Yon

    La Roche-sur-Yon, France

  • CHU Bordeaux

    Bordeaux, France

  • CHU Caen

    Caen, France

  • CHU Morvan de Brest

    Brest, 29609, France

  • CHU Pontchaillou

    Rennes, 35033, France

  • CHU Trousseau

    Tours, 37044, France

  • Hôtel Dieu

    Nantes, 44093, France