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Trial · Interventional

Active, not recruitingPhase 2Registry data

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

Short name ASTONISH

NCTNCT04055909 (opens ClinicalTrials.gov in a new tab)Other idMOT-C-203Other id2018-004827-36Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
355 participants (actual)
Sponsor
Inotrem · Industry
Design
Randomized · Quadruple masking
Countries
6 countries

Belgium, Denmark, Finland, France, Ireland, Spain

Start
13 Nov 2019
Primary completion
9 May 2022
Completion
9 May 2023 (estimated)
First posted
14 Aug 2019
Last update posted
11 Apr 2023
Conditions
Shock, Septic

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021202220232024
  1. Ph 2

    ASTONISH

    NCT04055909

    13 Nov 2019 to est. 9 May 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • nangibotide low doseDrug
  • nangibotide high doseDrug
  • placeboDrug

Arms3

  • Experimental

    nangibotide 1

    Treatment with study drug at at dose of 0.3mg/kg/hr

  • Experimental

    nangibotide 2

    Treatment with study drug at at dose of 1.0mg/kg/hr

  • Placebo comparator

    Placebo

    Treatment with a matched placebo infusion

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Sequential organ failure assessment (SOFA) score

    Time frame · day 5

    Registry description

    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 outcomes(14)

  1. All-cause mortality

    Time frame · day 5 and day 28

    Registry description

    all-cause mortality on D5 and D28

  2. Duration of ICU stay

    Time frame · day 28

    Registry description

    hospitalization

  3. Organe support free survival

    Time frame · day 28

    Registry description

    time to organe support free

  4. Sepsis support index (SSI)

    Time frame · day 28

    Registry description

    Sepsis support index

  5. Daily change of total Sequential organ failure assessment (SOFA) score and individual subscores

    Time frame · day 1, day 2, day 3, day 4, day 5, day 6 and day 7

    Registry description

    Daily change of total SOFA score and individual subscores

  6. Duration of Vasopressor use

    Time frame · day 28

    Registry description

    Change in the Duration of Vasopressor use

  7. Duration of Invasive mechanical ventilation (IMV)

    Time frame · day 28

    Registry description

    Change in the Duration of Invasive mechanical ventilation (IMV)

  8. Duration of Renal support

    Time frame · day 28

    Registry description

    Change in the Duration of renal replacement therapy, RRT

  9. All-cause mortality

    Time frame · 12 months

    Registry description

    all-cause mortality up to 12 months

  10. Septic shock related mortality at day 28

    Time frame · day 28

    Registry description

    mortality caused by septic shock

  11. Incidence of secondary infections and post shock antibiotic use

    Time frame · day 28

    Registry description

    Incidence of secondary infections and post shock antibiotic use

  12. Alive and organ support free at day 28

    Time frame · day 28

    Registry description

    Proportion of patients alive and free of organ support at day 28

  13. Overall survival on day 28

    Time frame · day 28

    Registry description

    time from the date of study drug start to date of death from any cause

  14. Overall survival up to 12 months

    Time frame · 12 months

    Registry description

    Overall survival up to 12 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

14 results

Prospective evaluation of the efficacy, safety, and optimal biomarker enrichment strategy for nangibotide, a TREM-1 inhibitor, in patients with septic shock (ASTONISH): a double-blind, randomised, controlled, phase 2b trial.

François et al. 2023The Lancet. Respiratory medicinecited by 71

PMID 37269870DOI 10.1016/s2213-2600(23)00158-3PUB-37269870

Full text at the publisher14 results
Publisher pageSee results (14)

More studies

1 study on this page

Indexing hint: Clinical trial · 2021

Rationale and protocol for the efficacy, safety and tolerability of nangibotide in patients with septic shock (ASTONISH) phase IIb randomised controlled trial.

Francois et al. 2021BMJ opencited by 15

PMID 34233965PMC8264912DOI 10.1136/bmjopen-2020-042921PUB-34233965

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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