A study evaluating the efficacy, safety and tolerability of Nangibotide in patients with septic shock.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Septic shock; MedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2018-004827-36-ES
• Lead Sponsor: INOTREM S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

1. Provide written informed consent (proxy/legal representative) according to local regulations
2. Age 18 to 85 years (inclusive)
Sepsis
3.Documented or suspected infection: lung, abdominal or urinary tract infection (UTI) in the elderly UTI (=65 years)
4.Organ dysfunction defined as acute change in total SOFA score = 2 points
Shock
5. Refractory hypotension requiring vasopressors to maintain MAP =65mm Hg despite adequate volume resuscitation (as per recommendations of the Surviving Sepsis Campaign)
6. Hyperlactatemia (blood lactate >2 mmol/L or 18 mg/dL). This criterion must be met at least once for the purpose of diagnosis within the 24 hours before study drug administration
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Previous episode of septic shock requiring vasopressor administration within current hospital stay
2. Underlying concurrent immunodepression with anti-CD52 alemtuzumab (Campath) or glucocorticoids >75 mg prednisone daily or equivalent for more than 7 days
3. Immunosuppressive therapy related to recent (<6 months) transplantation
4. Cancer chemotherapy (<3 months) implying an immunodepression
5. Known HIV infection with chronic low CD4 cell count (<200) for at least 6 months
6. Known pregnancy (positive urine or serum pregnancy test)
7. Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
8. Ongoing documented or suspected endocarditis
9. End-stage neurological disease
10. End-stage cirrhosis (Child Pugh Class C)
11. Acute Physiology and Chronic Health Evaluation (APACHE II) score <15 or = 34
12. Home oxygen therapy on a regular basis for > 6 h/day
13. Recent cardiopulmonary resuscitation (CPR) (within current hospital stay)
14. Body mass index (BMI) = 40 kg/m2 or weight = 130 kg
15. Moribund patients
16. Decision to limit full care taken before obtaining informed consent
17. Participation in another interventional study in the 3 months prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified