Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 16, 2017
First Posted Date  ICMJE May 18, 2017
Last Update Posted Date June 21, 2018
Actual Study Start Date  ICMJE July 3, 2017
Actual Primary Completion Date June 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
  • Vital signs [ Time Frame: 28 days ]
    systolic (SBP) and diastolic (DBP) blood pressure, heart rate, and body temperature (tympanic)
  • ECG [ Time Frame: 28 days ]
    12-lead ECG
  • Number of patients with clinically relevant abnormal laboratory values [ Time Frame: 28 days ]
    Laboratory tests related to hematology, biochemistry and coagulation
  • Presence of anti-LR12 antibodies [ Time Frame: 28 days ]
    Number of patients with anti-LR12 anti drug antibodies
  • Adverse events [ Time Frame: 28 days ]
    Number of patients with adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock
Official Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Shock, Septic
Intervention  ICMJE
  • Drug: MOTREM
    Formulated LR12 peptide
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: MOTREM 1
    0.3 mg/kg/h
    Intervention: Drug: MOTREM
  • Experimental: MOTREM 2
    1.0 mg/kg/h
    Intervention: Drug: MOTREM
  • Experimental: MOTREM 3
    3.0 mg/kg/h
    Intervention: Drug: MOTREM
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2017)
48
Actual Study Completion Date  ICMJE June 13, 2018
Actual Primary Completion Date June 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Netherlands,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03158948
Other Study ID Numbers  ICMJE MOT-C-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Inotrem
Study Sponsor  ICMJE Inotrem
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruno François, MD Inserm 1435 Clinical Investigational Center, Limoges, France
PRS Account Inotrem
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP