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Trial record 2 of 2 for:    Inotrem | Septic Shock

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158948
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Inotrem

Brief 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.

Condition or disease Intervention/treatment Phase
Shock, Septic Drug: MOTREM Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, Double-blind, Two-Stage, Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : June 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: MOTREM 1
0.3 mg/kg/h
Drug: MOTREM
Formulated LR12 peptide

Experimental: MOTREM 2
1.0 mg/kg/h
Drug: MOTREM
Formulated LR12 peptide

Experimental: MOTREM 3
3.0 mg/kg/h
Drug: MOTREM
Formulated LR12 peptide

Placebo Comparator: Placebo Drug: Placebo
placebo




Primary Outcome Measures :
  1. Vital signs [ Time Frame: 28 days ]
    systolic (SBP) and diastolic (DBP) blood pressure, heart rate, and body temperature (tympanic)

  2. ECG [ Time Frame: 28 days ]
    12-lead ECG

  3. Number of patients with clinically relevant abnormal laboratory values [ Time Frame: 28 days ]
    Laboratory tests related to hematology, biochemistry and coagulation

  4. Presence of anti-LR12 antibodies [ Time Frame: 28 days ]
    Number of patients with anti-LR12 anti drug antibodies

  5. Adverse events [ Time Frame: 28 days ]
    Number of patients with adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158948


Locations
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Belgium
Cliniques Universitaires Saint-Luc (there may be other sites in this country)
Brussels, Belgium
France
Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country)
Limoges Cedex, France
Netherlands
Radboudumc (there may be other sites in this country)
Nijmegen, Netherlands
Spain
Hospital Clínico San Carlos, Medicina Intensiva (there may be other sites in this country)
Madrid, Spain
Sponsors and Collaborators
Inotrem
Investigators
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Principal Investigator: Bruno François, MD Inserm 1435 Clinical Investigational Center, Limoges, France

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Responsible Party: Inotrem
ClinicalTrials.gov Identifier: NCT03158948    
Other Study ID Numbers: MOT-C-201
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inotrem:
Sepsis
LR12
TREM1
TREM-1
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation