A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
Recruiting
Phase 3
Interventional Study
Septic Shock
Sepsis
Hypovolemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 46 (estimated)
- Sponsor
- Vivacelle Bio · Industry
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About This Trial
This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female at least 18 years of age.
2. Evidence of bacterial infection demonstrated by positive blood culture and/or a known source of infection and/or an elevated procalcitonin of ≥ 2 ng/ml.
3. Patient has a mean blood pressure \< 65 mmHg that is unresponsive to fluids …
Contacts