Can a shot of interferon gamma help ventilated patients beat pneumonia faster?
NCT ID NCT05843786
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests whether a drug called interferon gamma can help intensive care patients recover more quickly from pneumonia they got while on a breathing machine. The drug aims to boost the immune system, which is often weakened after severe illness or injury. About 132 adults will receive either the drug or a placebo, and researchers will measure how many days they need the ventilator.
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 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jul 2027
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: * adult patients hospitalized in intensive care unit * under mechanical ventilation for more than 5 days * having a first episode of VAP (with a Clinical Pulmonary Infectious Score (CPIS score) \>6) * treated with antibiotics for less than 24 hours * with monocyte HLA-DR \< 8000 AB/C * written informed consent signed by the patient's trusted support person, or in the absence of the patient's representative and taking into account the agreement of the relative obtained by telephone emergency certificate completed and signed by the investigator * membership of a social security scheme Exclusion Criteria: * inability to administer the first dose of treatment in the study within 48 hours of the start of antibiotic therapy (antibiotic therapy for VAP) * Noradrenaline \> 0.25 mcg/kg/min * Immunosuppression, defined by: * solid tumor with chemotherapy in the last 3 months * progressive metastatic disease * hematological disease * solid organ transplantation * HIV infection (AIDS stage or not) * corticosteroid therapy at any dose for more than 3 months * ≥ 1 mg/kg of Prednisone equivalent for more than 7 days * immunosuppressive therapy * Head and/or cervical spine trauma : with a predictable impact on the duration of mechanical ventilation (left to the investigator's judgement), the investigator will assess whether the patient meets the following neurological criteria for extubation during their recovery: * A level of consciousness assessed as 0 or 1 on the Richmond Agitation-Sedation Scale (RASS) * FiO2 \<40% * PEEP level \<5 cmH2O * A FR/Vt ratio \<105 * Effective cough * Response to simple commands * Administration of noradrenaline \< 0.2 mcg/kg/min * Cardiocirculatory arrest * Burn patient * Cirrhosis with Child B or C score * Infection with Aspergillus spp. * Refusal to participate * Patient participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (excluding interventional research of 2° not interfering with the endpoints of the study according to the judgment of the principal investigator) * Lack of social coverage * Patient under curatorship or guardianship * Pregnant or breastfeeding women * Patient admitted to intensive care for SARS-Cov2 pneumonia * Known allergy to latex * Hypersensitivity to the active substance (interferon gamma-1b) or known hypersensitivity to related products, such as another interferon, or to any of the following excipients: Mannitol, Disodium succinate hexahydrate, Succinic acid, polysorbate 20 * Existence of chronic heart disease with FeVG\<45% * Major hepatic impairment (total bilirubin\>60 mg/L or 102 mcmol/L, equivalent to 3 SOFA points) * thrombocytopenia \<50000/mm3 (equivalent to 3 SOFA points) AST and/or ALT \> 5N Lipase \> 3N Severe chronic renal failure (creatinine clearance MDRD\< 10 ml/min/1.73m2) * Thrombocytopenia \<50,000/mm3 (equivalent to 3 SOFA points) * Respiratory failure requiring home oxygen therapy * Persons under court protection
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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
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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 Limoges
NOT_YET_RECRUITINGLimoges, France
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Département Anesthésie-Réanimation
NOT_YET_RECRUITINGSaint-Etienne, 42055, France
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Hôpital Edouard Herriot - Médecine intensive - réanimation
NOT_YET_RECRUITINGLyon, France
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Médecine intensive- Réanimation
RECRUITINGParis, 75014, France
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Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire
RECRUITINGLyon, 69003, France
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Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud
RECRUITINGPierre-Bénite, 69395, France
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Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard
NOT_YET_RECRUITINGNancy, 54511, France
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Service de reanimation chirurgicale Hopital Croix-Rousse
NOT_YET_RECRUITINGLyon, 69004, France
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Service de reanimation médicale hôpital de la Croix-Rousse
RECRUITINGLyon, 69004, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immune 'Power Meter' could flag pneumonia relapses in ventilated patients
- Can a smart oxygen device shorten hospital stays for pneumonia?
- New biomarkers could speed up pneumonia diagnosis in ICU patients
- New device aims to prevent pneumonia in ventilator patients
- Brain wave monitor may reduce sedative use in heart surgery ICU patients
- Simple toothbrushing may cut ventilator pneumonia risk