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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 : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Inotrem

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.


Condition or disease Intervention/treatment Phase
Shock, Septic Drug: nangibotide low dose Drug: nangibotide high dose Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study
Actual Study Start Date : November 13, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: nangibotide 1 Drug: nangibotide low dose
nangibotide 0.3 mg/kg/h

Experimental: nangibotide 2 Drug: nangibotide high dose
nangibotide 1.0 mg/kg/h

Placebo Comparator: Placebo Drug: placebo
matching placebo




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: day 28 ]
    Survival and all-cause mortality on D28



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, history of prosthetic heart valves
  9. Prolonged QT syndrome
  10. End-stage neurological disease
  11. End-stage cirrhosis (Child Pugh Class C)
  12. Acute Physiology and Chronic Health Evaluation (APACHE II) score <15 or ≥ 34
  13. Home oxygen therapy on a regular basis for > 6 h/day
  14. Recent cardiopulmonary resuscitation (CPR) (within current hospital stay)
  15. Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
  16. Moribund patients
  17. Decision to limit full care taken before obtaining informed consent
  18. Participation in another interventional study in the 3 months prior to randomization

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): NCT04055909


Contacts
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Contact: Jean-Jacques Garaud, MD +33 (0)9 66 81 79 00 astonish@inotrem.com

Locations
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Sponsors and Collaborators
Inotrem
Investigators
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Study Director: Jean-Jacques Garaud, MD CEO and Medical Officer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inotrem
ClinicalTrials.gov Identifier: NCT04055909    
Other Study ID Numbers: MOT-C-203
2018-004827-36 ( EudraCT Number )
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inotrem:
Septic Shock
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Nangibotide
Anti-Inflammatory Agents