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Can a booster shot for the immune system prevent more infections in sepsis survivors?

NCT ID NCT02361528

Disease control Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called GM-CSF in 166 ICU patients who had severe sepsis or septic shock and a weakened immune system. The goal was to see if the drug could reduce the number of new infections acquired in the ICU. Patients received either GM-CSF or a placebo, and researchers tracked infections and survival up to one year.

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

166 people

The number who actually took part.

Started

Sep 2015

Finished

Jun 2018

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: ICU patients presenting a severe sepsis or a septic shock associated with a sepsis-induced immunosuppression. 1. \- Severe sepsis OR septic shock defined by the association of: at least 2 criteria of Systemic Inflammation Response Syndrome (SIRS) a clinically or microbiologically defined infection and respectively at least one organ failure (level ≥ 2 in one organ failure of the SOFA score) OR the need of a vasopressor treatment (epinephrine or norepinephrine ≥ 0,25mg/kg/min for at least 6 hrs to maintain a systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥ 65 mmHg). 2. \- AND Sepsis-induced immunosuppression: reduced mHLA-DR levels (\< 8,000 monoclonal antibodies (mAb) per cell at D3). Exclusion Criteria: 1. \- Therapeutic limitation 2. Evolutive hemopathy, neutropenia \< 500/mm3, stemcell transplant 3. Solid tumor with on-going chemotherapy or radiotherapy 4. Human immunodeficiency virus (HIV) infection with CD 4 count \< 200 cell/mm3 5. Immunosuppressive treatment (including corticosteroid at immunosuppressive dose : \> 10 mg equivalent prednisolone and cumulative dose \> 700 mg) 6. Primary immunodeficiency . 7. Extra corporeal circulation within one month 8. Recent cardio-pulmonary resuscitation (within the current clinical episode) 9. Patients admitted in ICU for extensive burns 10. Contraindications to sargramostim 11. Pregnant or lactating women 12. Participation to another interventional study.

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Conditions

The condition(s) this trial relates to.

Sepsis toxic shock syndrome nosocomial infection prevention target

As listed by the trial registrant

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

Septic shock Severe sepsis

Contacts and locations

Locations

  • APHM Hopital Nord

    Marseille, 13915, France

  • APHM Hopital de la Timone

    Marseille, 13005, France

  • CHU Amiens Hopital SUD

    Amiens, 80054, France

  • CHU Estaing 1 place Lucie et Raymond Aubrac

    Clermont-Ferrand, 63003, France

  • CHU Gabriel MONTPIED

    Clermont-Ferrand, 63003, France

  • CHU Hopital Nord

    Saint-Etienne, 42055, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU de Grenoble- Hopital Michallon

    Grenoble, 38043, France

  • CHU de Grenoble-Hopital Michallon

    Grenoble, 38043, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • CHU de Saint-Etienne

    Saint-Etienne, 42055, France

  • CHU la Conception

    Marseille, 13005, France

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Hopital Edouard Herriot

    Lyon, 69003, France

  • Hopital Saint Eloi

    Montpellier, 34295, France

  • Hopital de la Croix Rousse

    Lyon, 69317, France

  • PTMC CHU de Nantes

    Nantes, 44093, France

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