Procollagen-3 driven corticosteroids for persistent Acute Respiratory Distress Syndrome

Phase 1

• Conditions: Acute Respiratory Distress Syndrome; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-002867-16-FR
• Lead Sponsor: Assistance Pubique Hôpitaux de Marseille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-18
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Age >= 18 years
Continuous endotracheal ventilation
Moderate – severe ARDS according to Berlin definition (see appendix) with PaO2/FiO2 = 200 with PEEP>=5 cm H2O
(For patients under ECMO, arterial blood gases have to be measured with a pump blood flow of 3 L/min and a FDO2 of 0.21 and FiO2 on mechanical ventilator of 1)
Date of ARDS onset : >=day 5 and = day 14 after the onset of ARDS criteria (regardless of ARDS severity)
Procollagen III above 9 µg/L in a bronchoalveolar lavage performed by the attending physician between day 3 and day 13 after the onset of ARDS and realized within 5 days prior to randomization
Written informed consent of patient or proxy
Patients covered by or having the rights to social security

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 178
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 178

Exclusion Criteria

•Lack of informed consent
•Patients deprived of freedom or under legal authority
•Patients not insured under the national social security system
•Known pregnancy or breast feeding
•Participation to another interventional trial within 30 days with mortality or ventilator free days as the main endpoint
•Clinical evidence of active untreated infection
•A known, undrained abscess (e.g., Staphylococcal lung abscess or loculated empyema or intra-abdominal abscess)
•Intravascular nidus of infection (e.g., bacterial or fungal endocarditis or suppurate thrombophlebitis), even if it is being treated with antibiotics.
•Disseminated fungal infection (EORTC criteria), even if being treated
•Active tuberculosis, even if being treated
•New nosocomial infection with less than 72 hours of antibiotics
•Burns requiring skin grafting
•Acquired immunodeficiency syndrome
•Treatment with corticosteroids (> 200 mg/day of hydrocortisone or equivalent at any moment during the month preceding inclusion)
•Cytotoxic therapy within 3 weeks
•Myeloproliferative syndrome
•SAPS II score at the time of enrollment > 75
•Presence of an advanced directive to withhold life-sustaining treatment or decision to withhold life-sustaining treatment
•Chronic respiratory disease requiring home oxygen therapy or ventilation
•Chronic interstitial or fibrotic lung disease or diffuse alveolar hemorrhage from vasculitis
•Acute or chronic liver disease defined as a Child-Pugh score of C.
•Preexisting neurological disease with diaphragmatic components (traumatic tetraplegia, amyotrophic lateral sclerosis, diaphragm paralysis…)
•Myasthenia gravis, Guillain-Barré Syndrome and others polyradiculoneuropathies
•Known or suspected allergy to methylprednisolone

Study & Design

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