Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock

• Status: Completed
• Trial end date: 2018-06-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of MOTREM versus placebo in adult patients with septic shock.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inotrem

Criteria

Inclusion Criteria:

• Provide written informed consent (proxy/legal representative) according to local regulations

• Age 18 to 80 years

• Documented or suspected infection: lung, abdominal or elderly UTI (≥65 years)

• Organ dysfunction defined as acute change in SOFA score ≥ 2 points

• Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation of at least 20 ml/kg within 6 hours

• 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

Exclusion Criteria: -

• Previous episode of septic shock (vasopressor administration) within current hospital stay

• Underlying concurrent immunodepression (specified in appendix 2)

• Solid organ transplant requiring immunosuppressive therapy

• Known pregnancy (positive serum pregnancy test)

• Prolonged QT syndrome (QTc ≥ 440 ms)

• Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding

• Ongoing documented or suspected endocarditis, history of prosthetic heart valves

• End-stage neurological disease

• End-stage cirrhosis (Child Pugh Class C)

• Acute Physiology And Chronic Health Evaluation (APACHE) II score ≥ 34

• End stage chronic renal disease requiring chronic dialysis

• Home oxygen therapy on a regular basis for > 6 h/day

• Severe obesity (BMI ≥ 40)

• Recent CPR (within current hospital stay)

• Moribund patients

• Decision to limit full care taken before obtaining informed consent

• Participation in another interventional study in the 3 months prior to randomisation