Status:
UNKNOWN
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
Lead Sponsor:
Nantes University Hospital
Conditions:
Critically Ill Patients
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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...
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): ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- 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.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04793568
Start Date
March 29 2021
End Date
June 1 2023
Last Update
February 16 2022
Active Locations (18)
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1
Angers University Hospital
Angers, France
2
Argenteuil Hospital
Argenteuil, France
3
Brest University Hospital
Brest, France
4
Beaujon University Hospital
Clichy, France