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

Shock, Septic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158948
• Other study ID #: MOT-C-201
• Status: Completed
• Phase: Phase 2
• Start date: July 3, 2017
• Est. completion date: June 13, 2018

Study information

• Verified date: June 2018
• Source: Inotrem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Intervention

Drug:
• MOTREM
Formulated LR12 peptide
• Placebo
placebo

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc (there may be other sites in this country)	Brussels
France	Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country)	Limoges Cedex
Netherlands	Radboudumc (there may be other sites in this country)	Nijmegen
Spain	Hospital Clínico San Carlos, Medicina Intensiva (there may be other sites in this country)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Inotrem

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs	systolic (SBP) and diastolic (DBP) blood pressure, heart rate, and body temperature (tympanic)	28 days
Primary	ECG	12-lead ECG	28 days
Primary	Number of patients with clinically relevant abnormal laboratory values	Laboratory tests related to hematology, biochemistry and coagulation	28 days
Primary	Presence of anti-LR12 antibodies	Number of patients with anti-LR12 anti drug antibodies	28 days
Primary	Adverse events	Number of patients with adverse events	28 days