Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients with Septic Shock. A Randomised, Double-blind, Two-stage, Placebo Controlled Study. - N/A

INOTREM S.A.0 个研究点目标入组 48 人开始时间: 2017年4月5日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

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

•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

发起方

INOTREM S.A.