Pneumonia, Ventilator-AssociatedPhase 3IGNORANTNCT05843786
Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients
A Phase 3 study testing Interferon gamma in people with Pneumonia, Ventilator-Associated, run by Hospices Civils de Lyon at 9 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated
- What is being tested?
- Interferon gamma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 9 sitesFrance
- Study dates
- 30 Jun 2023to 30 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 37Show fewer
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
CHU Limoges
Limoges
Olivier PLATEKER, MD
Olivier PLATEKER, MD
- Recruiting
Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire
Lyon, 69003
Anne-Claire LUKASZEWICZ, Pr
Anne-Claire LUKASZEWICZ, Pr
- Not yet recruiting
Service de reanimation chirurgicale Hopital Croix-Rousse
Lyon, 69004
Marie-Charlotte DELIGNETTE, MD, 4 72 11 89 47 ext. +33, marie-charlotte.delignette@chu-lyon.fr
Marie-Charlotte DELIGNETTE, MD
- Recruiting
Service de reanimation médicale hôpital de la Croix-Rousse
Lyon, 69004
Jean-Christophe RICHARD, Pr, 4 26 10 92 72 ext. +33, j-christophe.richard@chu-lyon.fr
Jean-Christophe RICHARD, Pr
- Not yet recruiting
Hôpital Edouard Herriot - Médecine intensive - réanimation
Lyon
Laurent ARGAUD, MD
Laurent ARGAUD, MD
- Not yet recruiting
Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard
Nancy, 54511
Marie-Reine Marie-Reine LOSSER, Pr, 3 83 15 41 66 ext. +33, mr.losser@chru-nancy.fr
Marie-Reine LOSSER, Pr
- Recruiting
Médecine intensive- Réanimation
Paris, 75014
Frederic PENE, Pr, 1 58 41 25 36 ext. +33, frederic.pene@aphp.fr
Frederic PENE, Pr
- Recruiting
Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud
Pierre-Bénite, 69395
Florent WALLET, MD, 4 78 86 19 21 ext. +33, florent.wallet@chu-lyon.fr
Florent WALLET, MD
- Not yet recruiting
Département Anesthésie-Réanimation
Saint-Etienne, 42055
Ludivine PETIT, MD, 6 77 81 86 87 ext. +33, Ludivine.Petit@chu-st-etienne.fr
Ludivine PETIT, MD
About this study
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.
- Conditions
- Pneumonia, Ventilator-Associated
- Being tested
- Interferon gamma, Placebo
- Keywords
- Critical Illness, Interferon-gamma, Immunodepression, Sepsis, Trauma, Monocyte HLA-DR, immunostimulation
- Medical subject headings
- Pneumonia, Ventilator-Associated, Critical Illness, Sepsis, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gammaDrug
Daily subcutaneous administration of Interferon gamma during 5 days
PlaceboDrug
Placebo during 5 days
| Study group | Role | What they receive |
|---|---|---|
| Interferon gamma treatment | Experimental | Interferon gamma treatment (100 micrograms /day during 5 days) Receives: Drug: Interferon gamma |
| Placebo | Placebo comparator | The comparator drug (placebo) is an injectable solution of sodium chloride 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of mechanical ventilation assessed from the first day of VAP diagnosis
mechanical ventilation-free days (VFD) from extubation through D28. A beneficial effect of using recombinant human interferon gamma-1b would be a statistically significant increase in VFD in patients receiving study drug in this setting compared to the group receiving placebo.
Measured: Day 28
Secondary outcomes (9)
All-cause mortality in intensive care
Measured: Day 28
Previous positive microbiological sample at inclusion becomes negative
Previous positive microbiological sample at inclusion becomes negative, i.e. pulmonary, urinary, blood cultures
Measured: Day 5
Length of stay in intensive care unit
Measured: Day 28
length of stay at hospital
Measured: Day 28
occurrence of another episode of VAP before extubation
Measured: Day 28
occurrence of another episode of infection acquired in intensive care unit
Measured: Day 28
increase of monocytic HLA-DR expression above 8000 AB/C the day after the last dose of treatment (J5)
Measured: Day 28
increase or decrease of blood leucocyte count at the day after the last dose of treatment (J5) in comparison to baseline
Measured: Day 28
Evaluation of the economic efficiency of the administration of IFN-γ (assessed by the ACER (average cost-effectiveness ratio) method)
Evaluation of the cost-effectiveness of IFN-γ administration (assessed by the ACER (average cost-effectiveness ratio) method)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start30 Jun 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Claire LUKASZEWICZ, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843786
- Sponsor's protocol ID
- 69HCL22_0851
- Other IDs
- 2022-502229-16-00
- Acronym
- IGNORANT
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients
- ClinicalTrials.gov ID
- NCT05843786
- Acronym / sponsor ID
- IGNORANT / 69HCL22_0851
- Conditions
- Pneumonia, Ventilator-Associated
- Keywords
- Critical Illness, Interferon-gamma, Immunodepression, Sepsis, Trauma, Monocyte HLA-DR, immunostimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon gamma treatment | Experimental | Drug: Interferon gammaInterferon gamma treatment (100 micrograms /day during 5 days) |
| Placebo | Placebo comparator | Drug: PlaceboThe comparator drug (placebo) is an injectable solution of sodium chloride 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (37 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon gammaDaily subcutaneous administration of Interferon gamma during 5 days | Drug | Interferon gamma treatment |
| PlaceboPlacebo during 5 days | Drug | Placebo |
Primary outcome
duration of mechanical ventilation assessed from the first day of VAP diagnosis
Time frame: Day 28
mechanical ventilation-free days (VFD) from extubation through D28. A beneficial effect of using recombinant human interferon gamma-1b would be a statistically significant increase in VFD in patients receiving study drug in this setting compared to the group receiving placebo.
9 secondary outcomes
All-cause mortality in intensive care
Time frame: Day 28
Previous positive microbiological sample at inclusion becomes negative
Time frame: Day 5
Length of stay in intensive care unit
Time frame: Day 28
length of stay at hospital
Time frame: Day 28
occurrence of another episode of VAP before extubation
Time frame: Day 28
occurrence of another episode of infection acquired in intensive care unit
Time frame: Day 28
increase of monocytic HLA-DR expression above 8000 AB/C the day after the last dose of treatment (J5)
Time frame: Day 28
increase or decrease of blood leucocyte count at the day after the last dose of treatment (J5) in comparison to baseline
Time frame: Day 28
Evaluation of the economic efficiency of the administration of IFN-γ (assessed by the ACER (average cost-effectiveness ratio) method)
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne-Claire LUKASZEWICZ, Pr principal investigator
Hospices Civils de Lyon
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon gamma in people with Pneumonia, Ventilator-Associated, run by Hospices Civils de Lyon at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Claire LUKASZEWICZ, Pr (472 11 13 27 ext. +33, anne-claire.lukaszewicz@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of mechanical ventilation assessed from the first day of VAP diagnosis (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.