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New treatment option for Pneumonia, Ventilator-Associated
Official title Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients
ClinicalTrials.gov ID: NCT05843786
What this study is testing
What is Interferon gamma?
Interferon gamma is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for pneumonia, ventilator-associated.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- membership of a social security scheme
- 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...
- 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 treatment research in progress or including an exclusion period still in progress at pre-inclusion (excluding treatment research of 2° not interfering with the endpoints of the study...
- 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...
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Limoges, France
- Lyon, France
- Nancy, France
- Paris, France
- Pierre-Bénite, France
- Saint-Etienne, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Limoges, France; Lyon, France; Nancy, France; Paris, France; Pierre-Bénite, France; Saint-Etienne, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.