Study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of MOTREM in patients with septic shock.

Phase 1

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

• Registration Number: EUCTR2016-005032-14-NL
• Lead Sponsor: INOTREM S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-05
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Provide written informed consent (proxy/legal representative) according to local regulations
2. Age 18* to 80 years
* 16 to 80 years in the Netherlands

Sepsis
3. Documented or suspected infection: lung, abdominal or elderly UTI (= 65 years)
4. Organ dysfunction defined as acute change in SOFA score = 2 points

Shock
5. Refractory hypotension requiring vasopressors to maintain MAP =65 mmHg despite adequate volume resuscitation of at least 20 ml/kg within 6 hours
6. Hyperlactatemia (blood lactate > 2mmol/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? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Previous episode of septic shock (vasopressor administration) within current hospital stay
2. Underlying concurrent immunodepression
3. Solid organ transplant requiring immunosuppressive therapy
4. Known pregnancy (positive serum pregnancy test)
5. Prolonged QT syndrome (QTc = 440 ms)
6. Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
7. Ongoing documented or suspected endocarditis, history of prosthetic heart valves
8. End-stage neurological disease
9. End-stage cirrhosis (Child Pugh Class C)
10. Acute Physiology And Chronic Health Evaluation (APACHE) II score = 34
11. End stage chronic renal disease requiring chronic dialysis
12. Home oxygen therapy on a regular basis for > 6 h/day
13. Severe obesity (BMI = 40)
14. Recent CPR (within current hospital stay)
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 randomisation

Study & Design

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