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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03158948
• Date of registration: 16/05/2017
• Prospective Registration: Yes
• Primary sponsor: Inotrem
• Public title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock
• Scientific 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
• Date of first enrolment: July 3, 2017
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03158948
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Netherlands, Spain

Contacts

• Name: Bruno François, MD
• Affiliation: Inserm 1435 Clinical Investigational Center, Limoges, France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Shock, Septic

Intervention(s)

Drug: Placebo

Drug: MOTREM

Primary Outcome(s)

Vital signs [Time Frame: 28 days]

ECG [Time Frame: 28 days]

Adverse events [Time Frame: 28 days]

Presence of anti-LR12 antibodies [Time Frame: 28 days]

Number of patients with clinically relevant abnormal laboratory values [Time Frame: 28 days]

Secondary ID(s)

MOT-C-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors