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VBI-S for Septic Shock (VBI-S-02 Trial)

Phase 3
Recruiting
Led By Cuthbert O Simpkins, MD, FACS
Research Sponsored by Vivacelle Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sequential Organ Failure Assessment (SOFA) score ≥ 5 and ≤ 11 with the maximum SOFA score of 24.
Failure of standard therapy defined as no decrease in the SOFA score for 48 hours or a SOFA score > 11 on admission to the ICU.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new treatment, VBI-S, to see if it can increase the blood pressure of patients with septic shock who have low blood volume.

Who is the study for?
Adults at least 18 years old with septic shock and low blood pressure not improved by current fluids can join. They must have a moderate SOFA score (5-11), no improvement or high SOFA score upon ICU admission, signs of infection, fever or hypothermia, fast breathing, lactate levels above normal, and heart rate over 90.
What is being tested?
The trial is testing VBI-S's ability to raise blood pressure in patients with septic shock due to low blood volume. It's an open-label study where everyone knows what treatment they're getting and it compares VBI-S against standard treatments.
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions at the infusion site, changes in heart rate or rhythm, allergic reactions, or other impacts on organ function related to changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My SOFA score is between 5 and 11, indicating some organ failure.
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My condition did not improve after standard treatment in the ICU.
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My average blood pressure is below 65 mmHg and doesn't improve with fluids.
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I have had a fever over 101°F recently.
Select...
I breathe rapidly, over 20 times a minute.
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I have a bacterial infection confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Elevation in Average Mean Arterial Pressure
Secondary study objectives
Arterial Oxygen Saturation
Dose of Pressor Drugs
Partial Pressure of Oxygen
+5 more
Other study objectives
Adverse Drug Reactions

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: VBI-SExperimental Treatment1 Intervention
Treatment with VBI-S

Find a Location

Who is running the clinical trial?

Vivacelle BioLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Cuthbert O Simpkins, MD, FACSPrincipal InvestigatorVivacelle Bio
~20 spots leftby Mar 2025
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