BridgeMD
A WORLD-WIDE CLINICAL STUDY TO FIND OUT IF INTRAVENOUS RECOMBINANT HUMAN PLASMA GELSOLIN IS SAFE AND IS BENEFICIAL FOR TREATING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) CAUSED BY PNEUMONIA OR OTHER INFECTIONS
EU CTIS ID: 2023-510109-16-00
What this study is testing
To assess the efficacy of IV rhu-pGSN plus SOC vs placebo plus SOC (hereafter referred to as rhu-pGSN vs placebo) administered to subjects with a primary diagnosis of moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist: - Investigator or designee to note radiologic findings in the electronic case report form (eCRF); - Radiology report and conclusion should be summarized in the eCRF; - A digital copy of the radiograph saved for review.
- 2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150 in any position). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.
- 3. Age ≥18 years
- 4. Informed consent obtained from subject/next of kin/legal proxy
- 5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team.
- 6. During the course of the study starting at screening and for 4 days after the final study treatment, for a total of 10 days: a. Female subjects of childbearing potential must agree to abstinence or use 2 medically accepted and approved birth control methods b. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner c. All subjects must agree not to donate sperm or eggs
You likely can't join if
- 1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings as assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.
- 6. Previous splenectomy
- 7. Immunosuppressed condition
- 8. Any vaccination in the previous 30 days
- 9. Participation in an interventional clinical trial (e.g., device, drug, or biologic) in the previous 30 days or 5 half-lives of the previous medicinal product, if longer
- 14. Chronic mechanical ventilation or dialysis
See the full eligibility criteria
Who can join
- 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist: - Investigator or designee to note radiologic findings in the electronic case report form (eCRF); - Radiology report and conclusion should be summarized in the eCRF; - A digital copy of the radiograph saved for review.
- 2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150 in any position). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.
- 3. Age ≥18 years
- 4. Informed consent obtained from subject/next of kin/legal proxy
- 5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team.
- 6. During the course of the study starting at screening and for 4 days after the final study treatment, for a total of 10 days: a. Female subjects of childbearing potential must agree to abstinence or use 2 medically accepted and approved birth control methods b. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner c. All subjects must agree not to donate sperm or eggs
What rules you out
- 1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings as assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.
- 6. Previous splenectomy
- 7. Immunosuppressed condition
- 8. Any vaccination in the previous 30 days
- 9. Participation in an interventional clinical trial (e.g., device, drug, or biologic) in the previous 30 days or 5 half-lives of the previous medicinal product, if longer
- 14. Chronic mechanical ventilation or dialysis
- 15. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy <6 months unrelated to acute infection in the opinion of the Investigator.
- 10. Known allergy to study drug or excipients
- 11. Weight >125 kg or <32 kg
- 12. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months.
- 13. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease.
- 2. Systemic fungal, yeast, or parasitic, or mycobacterial infection
- 3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO).
- 4. Pregnant or lactating women.
- 5. Permanent tracheostomy or chronic ventilatory support
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.