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Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock (ASTONISH)

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ClinicalTrials.gov Identifier: NCT04055909
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Inotrem

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE August 14, 2019
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
Sequential organ failure assessment (SOFA) score [ Time Frame: day 5 ]
Change of total SOFA score from baseline to day 5 (in the subgroup defined by patients with elevated sTREM-1 baseline levels and in the overall population)
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
Sequential organ failure assessment (SOFA) score [ Time Frame: day 3 ]
Change of total SOFA score from baseline to day 3 (in the subgroup defined by patients with elevated sTREM-1 baseline levels and in the overall population)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
All-cause mortality [ Time Frame: day 28 ]
Survival and all-cause mortality on D28
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock
Official Title  ICMJE Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study
Brief Summary

This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.

All patients with a diagnosis of septic shock will be considered for study participation. All potential study patients will receive standard of care for the treatment of septic shock.

After screening for eligibility, patients meeting all inclusion and no exclusion criterion will be randomized. Patients will be randomized to one of three treatment arms.

Treatment with study drug must be initiated as early as possible, but no later than 24 hours after the onset of septic shock, defined by the start of vasopressor therapy.

Patients will be treated for at least 3 days with study drug. After the first 3 days of treatment, patients still requiring vasopressor will be treated until 24 hours after vasopressor withdrawal with a maximum treatment duration of 5 days.

Patients will be assessed at the End of Study (EoS) visit at day 28. After the last patient's day 28 visit, the study will be analyzed. Additional follow up (FU) visits will be conducted after 90 days, 6 and 12 months.

The objective of the study ist to compare the safety, tolerability and efficacy of two doses of nangibotide versus placebo, when given in addition to standard of care.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Shock, Septic
Intervention  ICMJE
  • Drug: nangibotide low dose
    nangibotide 0.3 mg/kg/h
  • Drug: nangibotide high dose
    nangibotide 1.0 mg/kg/h
  • Drug: placebo
    matching placebo
Study Arms  ICMJE
  • Experimental: nangibotide 1
    Intervention: Drug: nangibotide low dose
  • Experimental: nangibotide 2
    Intervention: Drug: nangibotide high dose
  • 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provide written informed consent
  2. Age 18 to 85 years (inclusive)
  3. Documented or suspected infection: lung, abdominal or urinary tract infection (UTI) in the elderly (≥65 years)
  4. Organ dysfunction defined as acute change in total SOFA score ≥ 2 points
  5. Refractory hypotension requiring vasopressors to maintain MAP ≥65mm Hg despite adequate volume resuscitation
  6. Hyperlactatemia (blood lactate >2 mmol/L or 18 mg/dL).

Exclusion Criteria:

  1. Previous episode of septic shock requiring vasopressor administration within current hospital stay
  2. Underlying concurrent immunodepression with anti-CD52 alemtuzumab (Campath) or glucocorticoids >75 mg prednisone daily or equivalent for more than 7 days
  3. Immunosuppressive therapy related to recent (<6 months) transplantation
  4. Cancer chemotherapy (<3 months) implying an immunodepression
  5. Known HIV infection with low CD4 cell count (<200) for at least 6 months
  6. Known pregnancy (positive urine or serum pregnancy test)
  7. Shock of any other cause, e.g. hypotension related to gastrointestinal bleeding
  8. Ongoing documented or suspected endocarditis
  9. End-stage neurological disease
  10. End-stage cirrhosis (Child Pugh Class C)
  11. Acute Physiology and Chronic Health Evaluation (APACHE II) score <15 or ≥ 34
  12. Home oxygen therapy on a regular basis for > 6 h/day
  13. Recent cardiopulmonary resuscitation (CPR) (within current hospital stay)
  14. Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
  15. Moribund patients
  16. Decision to limit full care taken before obtaining informed consent
  17. Participation in another interventional study in the 3 months prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Jacques Garaud, MD +33 (0)9 66 81 79 00 astonish@inotrem.com
Listed Location Countries  ICMJE Belgium,   France,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04055909
Other Study ID Numbers  ICMJE MOT-C-203
2018-004827-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Inotrem
Study Sponsor  ICMJE Inotrem
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean-Jacques Garaud, MD CEO and Medical Officer
PRS Account Inotrem
Verification Date February 2020

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