A Phase 3 interventional study of Methylprednisolone and Methylprednisolone placebo in Persistent ARDS, sponsored by Assistance Publique Hopitaux De Marseille. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 3, Interventional, and Treatment
Unresolved ARDS is defined by the persistence of ARDS criteria at the end of the first week of evolution despite an appropriate treatment of the cause of ARDS. A persistent ARDS is associated with an increased mortality and prolonged lengths of mechanical ventilation, ICU stay and hospitalization. Persistent ARDS is characterized by ongoing inflammation, parenchymal-cell proliferation, and fibroproliferation leading to disordered deposition of collagen. All of these pathways may be responsive to corticosteroid therapy.
Only two randomized controlled double-blinded trials assessed the use of corticosteroids for persistent ARDS. In 24 patients, Meduri et al. reported an improvement of lung function and survival (1). In 180 patients, Steinberg et al showed no effect of corticosteroids on survival (2). A lower risk of death was observed when corticosteroids were started before 14 days after the onset of ARDS (2).
Alveolar procollagen III is validated as a biomarker of active fibroproliferation. Alveolar procollagen III > 9 µg/L is associated to fibroproliferation (3).
As mortality was lower in patients who received corticosteroids while presenting a high alveolar level of procollagen III on inclusion, Steinberg et al. showed that patients presenting with a low level of procollagen III and treated with corticosteroids had an increased risk of death (2).
Investigatores hypothesize that the use of procollagen III could improve personalized decision-making regarding steroid treatment in patients presenting with persistent ARDS. The future of anti-fibrotic treatment, including corticosteroids, in persistent ARDS might propose to individualize the therapy according to the presence of an active fibroproliferative phase (precision or personalized medicine).
Exclusion Criteria:
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L will receive methylprednisolone
Drug: Methylprednisolone
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L will receive placebo
Drug: Methylprednisolone placebo
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L
Ventilator Free Days
Number of Ventilator Free Days to day 60
Time frame: 60 days
ICU and hospital mortality
Number of death or alive patients on ICU discharge
Time frame: 90 days
Plan to share: No
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Respiratory Distress Syndrome→
Assistance Publique Hopitaux De Marseille