Status:
ACTIVE_NOT_RECRUITING
Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock
Lead Sponsor:
Inotrem
Conditions:
Shock, Septic
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.
Detailed Description
All patients with a diagnosis of septic shock will be considered for study participation. All potential study patients will receive standard of care for the treatment of septic shock. After screening...
Eligibility Criteria
Inclusion
- Provide written informed consent
- Age 18 to 85 years (inclusive)
- Documented or suspected infection: lung, abdominal or urinary tract infection (UTI) in the elderly (≥65 years)
- Organ dysfunction defined as acute change in total SOFA score ≥ 2 points
- Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation
- Hyperlactatemia (blood lactate \>2 mmol/L or 18 mg/dL).
Exclusion
- Previous episode of septic shock requiring vasopressor administration within current hospital stay
- Underlying concurrent immunodepression with anti-CD52 alemtuzumab (Campath) or glucocorticoids \>75 mg prednisone daily or equivalent for more than 7 days
- Immunosuppressive therapy related to recent (\<6 months) transplantation
- Cancer chemotherapy (\<3 months) implying an immunodepression
- Known HIV infection with low CD4 cell count (\<200) for at least 6 months
- Known pregnancy (positive urine or serum pregnancy test)
- Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
- Ongoing documented or suspected endocarditis, history of prosthetic heart valves
- Prolonged QT syndrome
- End-stage neurological disease
- End-stage cirrhosis (Child Pugh Class C)
- Acute Physiology and Chronic Health Evaluation (APACHE II) score \<15 or ≥ 34
- Home oxygen therapy on a regular basis for \> 6 h/day
- Recent cardiopulmonary resuscitation (CPR) (within current hospital stay)
- Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
- Moribund patients
- Decision to limit full care taken before obtaining informed consent
- Participation in another interventional study in the 3 months prior to randomization
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2023
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT04055909
Start Date
November 13 2019
End Date
May 9 2023
Last Update
April 11 2023
Active Locations (43)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
2
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
3
UZ Gent
Ghent, Belgium, 9000
4
Centre hospitalier Jolimont-Lobbes
La Louvière, Belgium, 7100