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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients

Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients (NCT05843786) is a Phase 3 interventional studying Pneumonia, Ventilator-Associated, sponsored by Hospices Civils de Lyon. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Clinical presentation of patients after severe injury such as a severe infection, trauma or extensive burns is characterized by the simultaneous occurrence of dysregulation of the initial inflammatory response and immunosuppression associating quantitative and functional alterations of innate and adaptive immune cells. These acquired immune dysfunctions have been associated with an increased susceptibility to nosocomial infections, foremost among which are ventilator-associated pneumonia (VAP). Despite the implementation of a set of preventive measures, the incidence of these VAP remains high in intensive care, with rates in Europe of 1.5% per day of ventilation. Post-aggressive immunosuppression is characterized by the decrease in the expression of HLA-DR (belonging to the type II major histocompatibility complex, MHC-II) on the surface of monocytes (mHLA-DR). The administration of interferon gamma (IFNγ) can restore the level of mHLA-DR and may possibly improve the prognosis as an adjuvant therapy associated to antibiotics. However, the level of proof of this therapeutic strategy is low, limited to small cohorts of patients, or clinical studies without prior immunodepression assessment. The objective of this study is to conduct a randomized, double-blind, placebo-controlled superiority trial to assess the effect of IFNγ administration on the duration of mechanical ventilation following the first episode of VAP in patients having an HLA-DR \< 8000 AB/C All reported data about recombinant human IFNγ 1b for the control of secondary infections in patients with septic shock used the dose of 100 micrograms per day by subcutaneous route for 3 to 5 days . At this dose, no retrospective study has reported any serious adverse effects and recombinant human IFNγ 1b allows an increase in monocyte membrane expression of mHLA-DR.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Pneumonia, Ventilator-Associated, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 132 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Pneumonia, Ventilator-Associated subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Interferon gamma

Daily subcutaneous administration of Interferon gamma during 5 days

DRUG

Placebo

Placebo during 5 days

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

CHU Limoges
Limoges, France
Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire
Lyon, France
Service de reanimation chirurgicale Hopital Croix-Rousse
Lyon, France
Service de reanimation médicale hôpital de la Croix-Rousse
Lyon, France
Hôpital Edouard Herriot - Médecine intensive - réanimation
Lyon, France
Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard
Nancy, France
Médecine intensive- Réanimation
Paris, France
Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud
Pierre-Bénite, France
Département Anesthésie-Réanimation
Saint-Etienne, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05843786), the sponsor (Hospices Civils de Lyon), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05843786 clinical trial studying?

Clinical presentation of patients after severe injury such as a severe infection, trauma or extensive burns is characterized by the simultaneous occurrence of dysregulation of the initial inflammatory response and immunosuppression associating quantitative and functional alterations of innate and adaptive immune cells. These acquired immune dysfunctions have been associated with an increased susceptibility to nosocomial infections, foremost among which are ventilator-associated pneumonia (VAP). Despite the implementation of a set of preventive measures, the incidence of these VAP remains high … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05843786?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05843786?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05843786. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05843786. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.