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Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome (ProCoCo)

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ClinicalTrials.gov Identifier: NCT03371498
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Persistent ARDS Drug: Methylprednisolone Drug: Methylprednisolone placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2021


Arm Intervention/treatment
Experimental: Methylprednisolone Group
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

Placebo Comparator: Control Group
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




Primary Outcome Measures :
  1. Ventilator Free Days [ Time Frame: 60 days ]
    Number of Ventilator Free Days to day 60


Secondary Outcome Measures :
  1. ICU and hospital mortality [ Time Frame: 90 days ]
    Number of death or alive patients on ICU discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Continuous endotracheal ventilation
  • Moderate - severe ARDS according to Berlin definition with PaO2/FiO2 ≤ 200 with PEEP >= 5 cm H2O
  • 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

Exclusion Criteria:

  • 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
  • Intravascular nidus of infection
  • Disseminated fungal infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371498


Contacts
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Contact: Jean Marie FOREL, MD/PhD +33491965835 jean-marie.forel@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Jean Marie FOREL, MD/PhD       jean-marie.forel@ap-hm.fr   
Principal Investigator: Jean-Marie FOREL, MD/PhD         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03371498     History of Changes
Other Study ID Numbers: 2017-002867-16
2017-42 ( Other Identifier: AP-HM )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents