A Phase 2 interventional study of Recombinant Interferon gamma 1b (IMUKIN®) and Recombinant Interferon gamma 1b placebo in Critically Ill Patients, sponsored by Nantes University Hospital. Status unknown at 18 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by Nantes University Hospital · Phase 2, Interventional, and Treatment
PREV-HAP study is part of a larger project entitled 'Host-targeted Approaches for the Prevention and the treatment of Hospital-Acquired Pneumonia' (HAP2), funded by the European Union's H2020 research and innovation programme under grant agreement N°847782. HAP2 aims to develop stratified host-directed drugs and biomarkers to enhance the prevention and the treatment of HAP and develop precision medicine in infectious diseases. Its ambition is to revolutionize the management of HAP: capitalising on the novel concept of critical-illness related immunosuppression altering the host-pathogens interactions, the aim is to propose a complete reappraisal of the physiopathology of HAP based on the concept of respiratory dysbiosis.
The main hypothesis of the PREV-HAP study is that human recombinant Interferon gamma 1b (rHuIFN-γ, Imukin) treatment can restore immunity in critically ill patients and prevent Hospital-Acquired Pneumonia.
The hypothesesis is that the in vivo investigations of the host-pathogens interactions can be used for the stratification of patients into high/low risk and responders/non-responders to host-targeted prevention of hospital-acquired infections.
The involvement of a state of critical-illness related immunosuppression in the susceptibility to hospital-acquired pneumonia is widely accepted, and an emerging trend is that the development of drugs for the treatment of this acquired immunosuppression will prevent infection and enhance outcomes of hospitalized patients.
It has been demonstrated that the productions of IFN-γ by immune cells are decreased in critically ill patients, and that these defects are associated with the susceptibility to HAP. rHuIFN-γ has neither been tested nor is recommended as adjunctive treatment of patients with HAP. Based on these specific factors identified in the host response, it is proposed in this study to use rHuIFN-γ as novel preventive approach for HAP.
200 adult patients hospitalized in intensive care units, under mechanical ventilation in three European countries will be included in the trial, and will be randomized in 2 arms :
Arm 1 (rHu-IFNγ):
Arm 2 (Placebo):
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 109 is close to the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
Drug: Recombinant Interferon gamma 1b (IMUKIN®)
Drug: Recombinant Interferon gamma 1b placebo
100 µg/0,5ml subcutaneous injections from day 1 to day 9 (5 injections, i.e. 1 injection of 100 µg every 48h)
5 subcutaneous injections from day 1 to day 9 (i.e. 1 injection of 0,5ml every 48h).
To demonstrate the efficiency of rHuIFN-γ for the prevention of hospital-acquired pneumonia
Rate of the composite outcome at day 28 made of at least one item among the following: all cause mortality and/or hospital-acquired pneumonia
Time frame: Day 28
All-cause mortality [efficiency of rHu-IFN-γ, on pneumonia-associated morbidity and mortality reduction]
Rate of all-cause mortality at D28 and D90
Time frame: Day 28 and Day 90
Rate of HAP [efficiency]
Rate of HAP at D28
Time frame: Day 28
Bacterial ecology of the 1st episode of HAP [efficiency]
Bacterial ecology of the 1st episode of HAP (respiratory fluids)
Time frame: Day 28
Rate of ventilator-associated tracheobronchitis [efficiency]
Rate of ventilator-associated tracheobronchitis at D28 defined as at least two of the following criteria: body temperature \>38°C; leukocytosis\>12000 cells/mL, leucopenia \<4000 cells/mL, or purulent pulmonary secretions and a positive culture of a respiratory tract samples, without appearance of a new infiltrate or change in an existing infiltrate on chest radiography
Time frame: Day 28
Occurence of Acute Respiratory Distress Syndrome [efficiency]
Acute Respiratory Distress Syndrome within 28 days after randomization
Time frame: Day 28
Duration of antimicrobial therapy [efficiency]
Duration of antimicrobial therapy at D28, antibiotic free days at D28
Time frame: Day 28
Duration of mechanical ventilation [efficiency]
Duration of mechanical ventilation at D90, mechanical ventilation free days at D90
Time frame: Day 90
Duration of ICU hospitalization [efficiency]
Duration of ICU hospitalization at D90, Duration of hospitalization at D90.
Time frame: Day 90
Rate of SAEs and SUSARs [tolerance]
Rate of serious adverse effects and suspected unexpected serious adverse reaction (SUSAR) at D15
Time frame: Day 15
Rate of leukocytosis [tolerance]
Rate of leukocytosis at D15.
Time frame: Day 15
Rate of neutropenia [tolerance]
Rate of neutropenia at D15.
Time frame: Day 15
Rate of lymphopenia [tolerance]
Rate of lymphopenia at D15.
Time frame: Day 15
Rate of thrombopenia [tolerance]
Rate of thrombopenia at D15.
Time frame: Day 15
Rate of liver cytolysis [tolerance]
Rate of liver cytolysis (Increases in AST and/or ALT) at D15.
Time frame: Day 15
Rate of pancreatitis [tolerance]
Rate of pancreatitis (Increase in Lipase) at D15.
Time frame: Day 15
Rate of patients with episode of fever [tolerance]
Rate of patients with episode of fever (T° \> 38.3°C)
Time frame: Day 15
Rate of patients with episode of headache [tolerance]
Rate of patients with episode of headache
Time frame: Day 15
Rate of patients with episode of nausea [tolerance]
Rate of patients with episode of nausea
Time frame: Day 15
Rate of allergic reaction [tolerance]
Rate of major allergic reaction at D15 defined as systemic epidermic reaction, anaphylactic
Time frame: Day 15
Incidence of injection site reaction [tolerance]
Occurence of injection site reaction at D15
Time frame: Day 15
Rate of myalgia [tolerance]
Rate of myalgia at D15
Time frame: Day 15
Rate of arthralgia [tolerance]
Rate of arthralgia at D15
Time frame: Day 15
Rate of back pain [tolerance]
Rate of back pain at D15
Time frame: Day 15
Economic efficiency of rHu-IFN-γ in the prevention of pneumonia
Economic endpoint at 3 months: Incremental cost effectiveness ratio (ICER). Analysis using QALYs (Quality-Adjusted Life-Years) as a measure of effectiveness. QALYs are a measure of effectiveness specifically designed for economic evaluations.
Time frame: Day 90
To determine the suitability of rHu-IFN-γ from the patients' and relatives' perspectives using The Short Form (36) Health Survey
Changes in health-related quality of life (HRQoL) from one (M1) to three months (M3) after randomization measured with the Short Form (SF)-36 scale validated in French, Greek, and Spanish he SF-36 is a 36-item self-report questionnaire with 8 domains = Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health).The scores of each domain range from 0 to 100, a higher score indicating a better HRQoL.
Time frame: Day 90
To determine the suitability of rHu-IFN-γ from the patients' and relatives' perspectives using the Hospital Anxiety and Depression scale (HADS)
Changes in anxiety and depression from M1 to M3 measured with the HADS scale validated in French, Greek, and Spanish. The HADS is a 14-item self-report questionnaire with 2 domains (anxietyand depression). The scores for anxiety and depression range from 0 (no symptoms) to 21 (significant number of symptoms).
Time frame: Day 90
To determine the suitability of rHu-IFN-γ from the patients' and relatives' perspectives using Satisfaction With Life Scale (SWLS)
Changes in subjective well-being from M1 to M3 measured with the Satisfaction With Life Scale (SWLS) validated in French, Greek, and Spanish. The SWLS is a 5-item self-report questionnaire. The response scores to the five items are added together to provide a total score ranging from 5 (worst satisfaction level) to 35 (best level).
Time frame: Day 90
To determine the acceptability of rHu-IFN-γ from the patients' and relatives' perspectives
Adaptation of the patients to their health state and its evolution from M1 to M3 using differential item functioning and response shift analyses for HRQoL, anxiety and depression. Change in the meaning of patients' self-evaluation between groups (DIF) and over time (response shift) will be inferred by the change in the items' parameters of the Partial Credit Models.
Time frame: Day 90
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Nantes University Hospital