Human recombinant interferon gamma in the treatment of ventilator-acquired pneumonia in ICU patients. IGNORANT study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospices Civils De Lyon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

19 Jun 2023 → ongoing

Decision date (initial)

2023-04-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Hospices Civils de Lyon · Biomérieux

External identifiers

EU CT number

2022-502229-16-00

ClinicalTrials.gov

NCT05843786

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the efficacy of recombinant human interferon gamma in reducing the duration of mechanical ventilation during the first episode of VAP in a population of patients treated in intensive care in addition to antibiotic treatment and having an mHLA-DR < 8000AB/C.

Secondary objectives 8

1. mortality
2. microbiological healing
3. The occurrence of another episode of VAP before extubation
4. Length of stay in intensive care unit
5. length of stay at hospital
6. prevention of infectious recurrences
7. the host's immune response
8. Evaluation of the economic efficiency of the administration of IFN-γ

Conditions and MedDRA coding

Ventilator acquired pneumonia

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. adult patients hospitalized in intensive care unit
2. under mechanical ventilation for more than 5 days
3. having a first episode of VAP (with a CPIS score >6)
4. with monocyte HLA-DR < 8000 AB/C
5. 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
6. Affiliation to a social security scheme

Exclusion criteria 24

1. Noradrénaline > 0.25 mcg/kg/min
2. thrombocytopenia <50000/mm3 (equivalent to 3 SOFA points)
3. 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
4. Head and/or cervical spine trauma with a foreseeable impact on the duration of mechanical ventilation (left to the investigator's judgement)
5. Cardiocirculatory arrest
6. Burn patient
7. Cirrhosis with Child B or C score
8. Infection with Aspergillus spp.
9. Refusal to participate
10. 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)
11. AST and/or ALT > 5N
12. Lack of social coverage
13. Lipase > 3N
14. Severe chronic renal failure (creatinine clearance MDRD< 10 ml/min/1.73m2)
15. Patient under curatorship or guardianship
16. Pregnant or breastfeeding women
17. Patient admitted to intensive care for SARS-Cov2 pneumonia
18. Known allergy to latex
19. Hypersensitivity to the active substance (interferon gamma-1b) or known hypersensitivity to related products, such as other interferons, or to any of the following excipients: Mannitol, Disodium succinate hexahydrate, Succinic acid, polysorbate 20
20. Existence of chronic heart disease with FeVG<45%
21. Major hepatic impairment (total bilirubin>60 mg/L or 102 mcmol/L, equivalent to 3 SOFA points)
22. impossibility of administering the first dose of study treatment within 48 hours after the start of antibiotic therapy (antibiotic therapy for VAP)
23. Respiratory failure requiring home oxygen therapy
24. People placed under judicial protection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 8

1. All-cause mortality in intensive care at D28
2. Bacteriological samples become negative
3. The occurrence of another episode of VAP before extubation
4. length of stay in intensive care unit
5. length of stay at hospital
6. The evolution of monocytic HLA-DR kinetics
7. the evolution of leukocytes kinetics
8. Assessment of the economic efficiency of IFN-γ administration

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospices Civils De Lyon

Sponsor organisation

Hospices Civils De Lyon

Address

3 Quai Des Celestins, Bp 2251 Bp 2251

City

Lyon Cedex 02

Postcode

69229

Country

France

Scientific contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Anne-Claire Lukaszewicz

Public contact point

Organisation

Hospices Civils De Lyon

Contact name

Pr Anne-Claire Lukaszewicz

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications