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A Study of REGN7544 for the Treatment in Adult Patients with Sepsis-Induced Hypotension.
EU CTIS ID: 2024-514946-35-00
What this study is testing
To evaluate the effect of REGN7544 on vasopressor requirements in participants with sepsis-induced hypotension.
- 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
- Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period.
- Sepsis-induced hypotension that has not responded to intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol.
- Other protocol defined inclusion criteria apply.
You likely can't join if
- Unable to obtain informed consent by participant or Legally Authorized Representative (LAR).
- Other protocol-defined exclusion criteria apply.
- Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
- Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest.
- Ejection fraction <20% in the most recent known echocardiogram.
- Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization.
See the full eligibility criteria
- Proven or suspected infection defined as administration or planned administration of antimicrobial therapy within the screening period.
- Sepsis-induced hypotension that has not responded to intravenous (IV) fluids, receiving 1 or 2 vasopressors and maintaining a Mean Arterial Pressure (MAP) of ≥ 65 mm Hg for at least 2 consecutive hours immediately prior to randomization, as defined in the protocol.
- Other protocol defined inclusion criteria apply.
- Unable to obtain informed consent by participant or Legally Authorized Representative (LAR).
- Other protocol-defined exclusion criteria apply.
- Clinical status requires vasopressor and/or Blood Pressure (BP) management inconsistent with the study protocol
- Primary cause of hypotension suspected to be due to non-sepsis cause (eg, hemorrhage, burns, or cardiogenic shock), including shock after cardiac arrest.
- Ejection fraction <20% in the most recent known echocardiogram.
- Acute coronary syndrome based on clinical symptoms and/or electrocardiogram (ECG) during hospitalization.
- History of hospitalization due to heart failure, myocardial infarction, stroke, clinically significant ventricular arrhythmia, transient ischemic attack, or unstable angina within the preceding 3 months.
- Any prior diagnosis of severe pulmonary hypertension, as defined in the protocol.
- Receiving 3 or more vasopressors or exceeding the maximal combined dose as defined in the protocol, during the screening period or at the time of study drug administration.
- Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia.
The study team makes the final eligibility decision.
Where it's taking place
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.