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

Phase 1

• Conditions: Patients hospitalized in intensive care units, under mechanical ventilation; MedDRA version: 21.1Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10076918Term: Hospital acquired pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-000620-18-FR
• Lead Sponsor: antes University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

-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). If it 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•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)
•Immunodepression (hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, known infection Human immunodeficiency virus or 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified