Critically Ill PatientsPhase 2PREV-HAPNCT04793568

Human Recombinant Interferon Gamma-1b for the Prevention of Hospital-acquired Pneumonia in Critically Ill Patients: a Double-blind, International, Phase 2, Randomized, Placebo-controlled Trial - the PREV-HAP Study

A Phase 2 study testing Recombinant Interferon gamma 1b (IMUKIN®) in people with Critically Ill Patients, run by Nantes University Hospital at 18 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Critically Ill Patients
What is being tested?: Recombinant Interferon gamma 1b (IMUKIN®)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 109 participants
Where: 18 sitesin 3 countries
Study dates: 29 Mar 2021to Jun 2023
Phase: Phase 2
Are there results?: None posted in the registry

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (18yr to 85yr).
Hospitalized in intensive care unit for less than 48 hours.
Receiving invasive mechanical ventilation at the time of inclusion.
One or more acute organ failure at the time of inclusion among: neurological (Glasgow coma scale <13 before sedation), hemodynamic (norepinephrine, epinephrine, or any other vasopressor at a dose of ≥ 0.1 μg per kilogram of body weight per minute or ≥0.5 mg per hour for at least 6 hours), respiratory (PaO2 / FiO2< 200) and/or renal (creatininemia > 2 fold higher than the basal value and/or oliguria < 0.5 mL/kg/hour for at less 12 hours).
Informed consent from a legal representative, or emergency procedure (when possible according to national regulation, see below). As is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible.
Person insured under a health insurance scheme.

Who cannot join

Pregnant women (serum or urine test), breastfeeding women
Patient under legal protection (incl. under guardianship or trusteeship)
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
Severe hepatic insufficiency ( Child Pugh score B or C)
Liver cytolysis with hepatic enzymes (AST and/or ALT) > 5N
Severe chronic renal insufficiency (MDRD Creatinine Clearance < 10 ml/min/1.73m2)

Show all 12Show fewer

Immunosuppression (hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, known infection Human immunodeficiency virus, concomitant use of any anti-graft rejection drug).
Coma after resuscitated cardiac arrest
Cervical spinal cord injury
Participation to a drug interventional study within 1 month prior to the inclusion
Hospital-acquired pneumonia before inclusion in the study during the current hospitalization.
Sustained hyperlactatemia > 5 mmol/L.

Trial locations and contacts

18 sites in 3 countries.

Country

City, postcode or hospital

18 sites in 3 countries

France7 sites

Angers University Hospital
Angers
Argenteuil Hospital
Argenteuil
Brest University Hospital
Brest
Beaujon University Hospital
Clichy
Limoges University Hospital
Limoges
Nantes University Hospital
Nantes, 44093
Rennes University Hospital
Rennes

Other trials in France

Greece6 sites

Aghioi Anargyroi General Oncology Hospital
Athens
Attikon University General Hospital
Athens
General University Hospital of Heraklion
Heraklion
University General Hospital of Ioannina
Ioannina
General University Hospital of Larissa
Larissa
Koutlimbaneio & Triantafylleio General Hospital of Larissa
Larissa

Other trials in Greece

Spain5 sites

Hospital Clínic Barcelona
Barcelona
Hospital Vall d'Hebron
Barcelona
Hôpital universitaire Arnau de Vilanova
Lleida
Hospital Clínico San Carlos
Madrid
Hospital Universitario de Son Llátzer
Palma

Other trials in Spain

About this study

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.

Read the detailed description

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):

Recombinant Interferon gamma 1b (IMUKIN®, from Clinigen®): 100 µg/0,5ml subcutaneous injections from day 1 to day 9 (5 injections, i.e. 1 injection of 100 µg every 48h),

Arm 2 (Placebo):

Recombinant Interferon gamma 1b placebo: 5 subcutaneous injections from day 1 to day 9 (i.e. 1 injection of 0,5ml every 48h).

Conditions: Critically Ill Patients
Being tested: Recombinant Interferon gamma 1b (IMUKIN®), Recombinant Interferon gamma 1b placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Interferon gamma 1b (IMUKIN®)Drug
100 µg/0,5ml subcutaneous injections from day 1 to day 9 (5 injections, i.e. 1 injection of 100 µg every 48h)
Recombinant Interferon gamma 1b placeboDrug
5 subcutaneous injections from day 1 to day 9 (i.e. 1 injection of 0,5ml every 48h).

Study groups in NCT04793568
Study group	Role	What they receive
Recombinant Interferon gamma 1b (IMUKIN®)	Experimental	Not described Receives: Drug: Recombinant Interferon gamma 1b (IMUKIN®)
Recombinant Interferon gamma 1b placebo	Placebo comparator	Not described Receives: Drug: Recombinant Interferon gamma 1b placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 28

Secondary outcomes (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
Measured: Day 28 and Day 90
Rate of HAP [efficiency]
Rate of HAP at D28
Measured: Day 28
Bacterial ecology of the 1st episode of HAP [efficiency]
Bacterial ecology of the 1st episode of HAP (respiratory fluids)
Measured: 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
Measured: Day 28
Occurence of Acute Respiratory Distress Syndrome [efficiency]
Acute Respiratory Distress Syndrome within 28 days after randomization
Measured: Day 28
Duration of antimicrobial therapy [efficiency]
Duration of antimicrobial therapy at D28, antibiotic free days at D28
Measured: Day 28
Duration of mechanical ventilation [efficiency]
Duration of mechanical ventilation at D90, mechanical ventilation free days at D90
Measured: Day 90
Duration of ICU hospitalization [efficiency]
Duration of ICU hospitalization at D90, Duration of hospitalization at D90.
Measured: Day 90
Rate of SAEs and SUSARs [tolerance]
Rate of serious adverse effects and suspected unexpected serious adverse reaction (SUSAR) at D15
Measured: Day 15
Rate of leukocytosis [tolerance]
Rate of leukocytosis at D15.
Measured: Day 15
Rate of neutropenia [tolerance]
Rate of neutropenia at D15.
Measured: Day 15
Rate of lymphopenia [tolerance]
Rate of lymphopenia at D15.
Measured: Day 15
Rate of thrombopenia [tolerance]
Rate of thrombopenia at D15.
Measured: Day 15
Rate of liver cytolysis [tolerance]
Rate of liver cytolysis (Increases in AST and/or ALT) at D15.
Measured: Day 15
Rate of pancreatitis [tolerance]
Rate of pancreatitis (Increase in Lipase) at D15.
Measured: Day 15
Rate of patients with episode of fever [tolerance]
Rate of patients with episode of fever (T° > 38.3°C)
Measured: Day 15
Rate of patients with episode of headache [tolerance]
Rate of patients with episode of headache
Measured: Day 15
Rate of patients with episode of nausea [tolerance]
Rate of patients with episode of nausea
Measured: Day 15
Rate of allergic reaction [tolerance]
Rate of major allergic reaction at D15 defined as systemic epidermic reaction, anaphylactic
Measured: Day 15
Incidence of injection site reaction [tolerance]
Occurence of injection site reaction at D15
Measured: Day 15
Rate of myalgia [tolerance]
Rate of myalgia at D15
Measured: Day 15
Rate of arthralgia [tolerance]
Rate of arthralgia at D15
Measured: Day 15
Rate of back pain [tolerance]
Rate of back pain at D15
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 2021Jun 2023

First posted11 Mar 2021
Study start29 Mar 2021
Primary completion7 Nov 2021
Study completionJun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
More trials run by Nantes University HospitalThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04793568
Sponsor's protocol ID: RC20_0082
Acronym: PREV-HAP
Status last verified: Feb 2022
First submitted: 24 Feb 2021
Last updated: 16 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Petrier M, Sinha D, Martin FP, Poulain C, Flattres Duchaussoy D, Ziogas A, Novakovic B, Hurtado-Navarro L, Ferreira AV, Martens JHA, Koulenti D, Fernandez-Barat L, Torres A, Montassier E, Netea MG, Poschmann J, Roquilly A. Identification of a robust metabolic signature associated with hospital-acquired pneumonia and response to interferon-gamma treatment in critically ill patients. Crit Care. 2026 Mar 12;30(1):192. doi: 10.1186/s13054-026-05946-6.
PubMed 41820963
Anani H, Destras G, Regue H, Bulteau S, Bressollette-Bodin C, Roquilly A, Josset L. Metagenome-assembled complete genome of Bohxovirus, a virulent bacteriophage involved in the prediction of hospital-acquired pneumonia in intubated critically ill patients. Microbiol Resour Announc. 2025 Dec 11;14(12):e0059225. doi: 10.1128/mra.00592-25. Epub 2025 Oct 29.
PubMed 41159973
Bulteau S, Braud M, Petrier M, Castain L, Anani H, Peltier C, Mobuchon L, Bouras M, Flattres D, Poschmann J, Josset L, Roquilly A, Bressollette-Bodin C. Interferon Gamma Injection and Its Effect on the Respiratory Anelloviridae Population in ICU Ventilated Patients. J Med Virol. 2025 Oct;97(10):e70612. doi: 10.1002/jmv.70612.
PubMed 41036698
Anani H, Destras G, Bulteau S, Castain L, Semanas Q, Burfin G, Petrier M, Martin FP, Poulain C, Dickson RP, Bressollette-Bodin C, Roquilly A, Josset L. Lung virome convergence precedes hospital-acquired pneumonia in intubated critically ill patients. Cell Rep Med. 2025 Sep 16;6(9):102289. doi: 10.1016/j.xcrm.2025.102289. Epub 2025 Sep 5.
PubMed 40914165
Bouras M, Tessier P, Poulain C, Schirr-Bonnans S, Roquilly A. Three-month outcomes and cost-effectiveness of interferon gamma-1b in critically ill patients: a secondary analysis of the PREV-HAP trial. J Intensive Care. 2024 Oct 11;12(1):40. doi: 10.1186/s40560-024-00753-z.
PubMed 39394183

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Critically Ill Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Human Recombinant Interferon Gamma-1b for the Prevention of Hospital-acquired Pneumonia in Critically Ill Patients: a Double-blind, International, Phase 2, Randomized, Placebo-controlled Trial - the PREV-HAP Study
ClinicalTrials.gov ID: NCT04793568
Acronym / sponsor ID: PREV-HAP / RC20_0082
Conditions: Critically Ill Patients
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 109 participants (actual)
Lead sponsor: Nantes University HospitalUniversity, hospital or other
Study start: 29 Mar 2021 (actual)
Primary completion: 7 Nov 2021 (actual)
Study completion: Jun 2023 (estimated)
First posted: 11 Mar 2021 (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.

Detailed description

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):

Recombinant Interferon gamma 1b (IMUKIN®, from Clinigen®): 100 µg/0,5ml subcutaneous injections from day 1 to day 9 (5 injections, i.e. 1 injection of 100 µg every 48h),

Arm 2 (Placebo):

Recombinant Interferon gamma 1b placebo: 5 subcutaneous injections from day 1 to day 9 (i.e. 1 injection of 0,5ml every 48h).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Recombinant Interferon gamma 1b (IMUKIN®)	Experimental	Drug: Recombinant Interferon gamma 1b (IMUKIN®)
Recombinant Interferon gamma 1b placebo	Placebo comparator	Drug: Recombinant Interferon gamma 1b placebo

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult patients (18yr to 85yr).
Hospitalized in intensive care unit for less than 48 hours.
Receiving invasive mechanical ventilation at the time of inclusion.
One or more acute organ failure at the time of inclusion among: neurological (Glasgow coma scale <13 before sedation), hemodynamic (norepinephrine, epinephrine, or any other vasopressor at a dose of ≥ 0.1 μg per kilogram of body weight per minute or ≥0.5 mg per hour for at least 6 hours), respiratory (PaO2 / FiO2< 200) and/or renal (creatininemia > 2 fold higher than the basal value and/or oliguria < 0.5 mL/kg/hour for at less 12 hours).
Informed consent from a legal representative, or emergency procedure (when possible according to national regulation, see below). As is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible.

Key exclusion criteria (12 listed)

Pregnant women (serum or urine test), breastfeeding women
Patient under legal protection (incl. under guardianship or trusteeship)
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
Severe hepatic insufficiency ( Child Pugh score B or C)
Liver cytolysis with hepatic enzymes (AST and/or ALT) > 5N

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
Recombinant Interferon gamma 1b (IMUKIN®)100 µg/0,5ml subcutaneous injections from day 1 to day 9 (5 injections, i.e. 1 injection of 100 µg every 48h)	Drug	Recombinant Interferon gamma 1b (IMUKIN®)
Recombinant Interferon gamma 1b placebo5 subcutaneous injections from day 1 to day 9 (i.e. 1 injection of 0,5ml every 48h).	Drug	Recombinant Interferon gamma 1b placebo

Primary outcome

To demonstrate the efficiency of rHuIFN-γ for the prevention of hospital-acquired pneumonia
Time frame: Day 28
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

28 secondary outcomes

All-cause mortality [efficiency of rHu-IFN-γ, on pneumonia-associated morbidity and mortality reduction]
Time frame: Day 28 and Day 90
Rate of HAP [efficiency]
Time frame: Day 28
Bacterial ecology of the 1st episode of HAP [efficiency]
Time frame: Day 28
Rate of ventilator-associated tracheobronchitis [efficiency]
Time frame: Day 28
Occurence of Acute Respiratory Distress Syndrome [efficiency]
Time frame: Day 28
Duration of antimicrobial therapy [efficiency]
Time frame: Day 28
Duration of mechanical ventilation [efficiency]
Time frame: Day 90
Duration of ICU hospitalization [efficiency]
Time frame: Day 90
Rate of SAEs and SUSARs [tolerance]
Time frame: Day 15
Rate of leukocytosis [tolerance]
Time frame: Day 15
Rate of neutropenia [tolerance]
Time frame: Day 15
Rate of lymphopenia [tolerance]
Time frame: Day 15
Rate of thrombopenia [tolerance]
Time frame: Day 15
Rate of liver cytolysis [tolerance]
Time frame: Day 15
Rate of pancreatitis [tolerance]
Time frame: Day 15
Rate of patients with episode of fever [tolerance]
Time frame: Day 15
Rate of patients with episode of headache [tolerance]
Time frame: Day 15
Rate of patients with episode of nausea [tolerance]
Time frame: Day 15
Rate of allergic reaction [tolerance]
Time frame: Day 15
Incidence of injection site reaction [tolerance]
Time frame: Day 15
Rate of myalgia [tolerance]
Time frame: Day 15
Rate of arthralgia [tolerance]
Time frame: Day 15
Rate of back pain [tolerance]
Time frame: Day 15
Economic efficiency of rHu-IFN-γ in the prevention of pneumonia
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
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)
Time frame: Day 90
To determine the suitability of rHu-IFN-γ from the patients' and relatives' perspectives using Satisfaction With Life Scale (SWLS)
Time frame: Day 90
To determine the acceptability of rHu-IFN-γ from the patients' and relatives' perspectives
Time frame: Day 90

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
Derived from this study: PubMed 41820963Petrier M, Sinha D, Martin FP, Poulain C, Flattres Duchaussoy D, Ziogas A, Novakovic B, Hurtado-Navarro L, Ferreira AV, Martens JHA, Koulenti D, Fernandez-Barat L, Torres A, Montassier E, Netea MG, Poschmann J, Roquilly A. Identification of a robust metabolic signature associated with hospital-acquired pneumonia and response to interferon-gamma treatment in critically ill patients. Crit Care. 2026 Mar 12;30(1):192. doi: 10.1186/s13054-026-05946-6.
Derived from this study: PubMed 41159973Anani H, Destras G, Regue H, Bulteau S, Bressollette-Bodin C, Roquilly A, Josset L. Metagenome-assembled complete genome of Bohxovirus, a virulent bacteriophage involved in the prediction of hospital-acquired pneumonia in intubated critically ill patients. Microbiol Resour Announc. 2025 Dec 11;14(12):e0059225. doi: 10.1128/mra.00592-25. Epub 2025 Oct 29.
Derived from this study: PubMed 41036698Bulteau S, Braud M, Petrier M, Castain L, Anani H, Peltier C, Mobuchon L, Bouras M, Flattres D, Poschmann J, Josset L, Roquilly A, Bressollette-Bodin C. Interferon Gamma Injection and Its Effect on the Respiratory Anelloviridae Population in ICU Ventilated Patients. J Med Virol. 2025 Oct;97(10):e70612. doi: 10.1002/jmv.70612.
Derived from this study: PubMed 40914165Anani H, Destras G, Bulteau S, Castain L, Semanas Q, Burfin G, Petrier M, Martin FP, Poulain C, Dickson RP, Bressollette-Bodin C, Roquilly A, Josset L. Lung virome convergence precedes hospital-acquired pneumonia in intubated critically ill patients. Cell Rep Med. 2025 Sep 16;6(9):102289. doi: 10.1016/j.xcrm.2025.102289. Epub 2025 Sep 5.
Derived from this study: PubMed 39394183Bouras M, Tessier P, Poulain C, Schirr-Bonnans S, Roquilly A. Three-month outcomes and cost-effectiveness of interferon gamma-1b in critically ill patients: a secondary analysis of the PREV-HAP trial. J Intensive Care. 2024 Oct 11;12(1):40. doi: 10.1186/s40560-024-00753-z.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

18 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Interferon gamma 1b (IMUKIN®) in people with Critically Ill Patients, run by Nantes University Hospital at 18 sites in 3 countries.

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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France, Greece, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To demonstrate the efficiency of rHuIFN-γ for the prevention of hospital-acquired pneumonia (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04793568, which also lists 5 linked publications.

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 16 Feb 2022.