Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock
NCT ID: NCT04055909
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
355 participants
INTERVENTIONAL
2019-11-13
2023-05-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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nangibotide 1
Treatment with study drug at at dose of 0.3mg/kg/hr
nangibotide low dose
nangibotide 0.3 mg/kg/h
nangibotide 2
Treatment with study drug at at dose of 1.0mg/kg/hr
nangibotide high dose
nangibotide 1.0 mg/kg/h
Placebo
Treatment with a matched placebo infusion
placebo
matching placebo
Interventions
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nangibotide low dose
nangibotide 0.3 mg/kg/h
nangibotide high dose
nangibotide 1.0 mg/kg/h
placebo
matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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Inotrem
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Jacques Garaud, MD
Role: STUDY_DIRECTOR
CEO and Medical Officer
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Ziekenhuis Oost-Limburg
Genk, , Belgium
UZ Gent
Ghent, , Belgium
Centre hospitalier Jolimont-Lobbes
La Louvière, , Belgium
CHU Marie Curie
Lodelinsart, , Belgium
Clinique Saint-Pierre
Ottignies, , Belgium
CHU UCL Namur asbl
Yvoir, , Belgium
Nordsjællandshospital Hillerød
Hillerød, , Denmark
Helsinki University Hospital Adult ICU PPDS
Helsinki, , Finland
Kuopion Yliopistollinen sairaala
Kuopio, , Finland
Tampereen yliopistollinen sairaala
Tampere, , Finland
CHU Angers
Angers, , France
Centre hospitalier Victor Dupouy
Argenteuil, , France
Centre hospitalier de Béthune
Béthune, , France
Hôpital Fleyriat
Bourg-en-Bresse, , France
CHU Dijon - Hôpital François Mitterrand
Dijon, , France
CHD les Oudairies
La Roche-sur-Yon, , France
Hôpital de Bicêtre
Le Kremlin-Bicêtre, , France
CHU LE Mans
Le Mans, , France
CHRU Lille - Hôpital Roger Salengro
Lille, , France
Hôpital Universitaire Dupuytren
Limoges, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Hôpital Nord
Marseille, , France
Centre hospitalier de Melun
Melun, , France
CHRU Nancy - Hôpital Central
Nancy, , France
Hôtel Dieu - Nanates
Nantes, , France
CHU de Nîmes
Nîmes, , France
Hôpital de la source
Orléans, , France
Hôpital Lariboisière
Paris, , France
Hôpital Saint Louis
Paris, , France
Groupe hospitalier Pitié-Salpêtrière
Paris, , France
Hôpital Cochin
Paris, , France
CHRU Hôpital Bretonneau
Tours, , France
Hôpital d'instruction des Armées Robert Picqué
Villenave-d'Ornon, , France
St Jame's Hospital
Dublin, , Ireland
Galway University Hospital
Galway, , Ireland
Hospital del mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebrón
Barcelona, , Spain
Hospital Clinical San Carlos
Madrid, , Spain
Hospital Universitario Dentral de Asturias
Oviedo, , Spain
Hospital Universitari Mutua de Terrassa
Terrassa, , Spain
Hospital universitario DR. Peset Aleixandre
Valencia, , Spain
Hospital Universitario y Politecnico la Fe
Valencia, , Spain
Countries
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References
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Francois B, Lambden S, Fivez T, Gibot S, Derive M, Grouin JM, Salcedo-Magguilli M, Lemarie J, De Schryver N, Jalkanen V, Hicheur T, Garaud JJ, Cuvier V, Ferrer R, Bestle M, Pettila V, Mira JP, Bouisse C, Mercier E, Vermassen J, Huberlant V, Vinatier I, Anguel N, Levy M, Laterre PF; ASTONISH investigators. 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. Lancet Respir Med. 2023 Oct;11(10):894-904. doi: 10.1016/S2213-2600(23)00158-3. Epub 2023 May 31.
Francois B, Lambden S, Gibot S, Derive M, Olivier A, Cuvier V, Witte S, Grouin JM, Garaud JJ, Salcedo-Magguilli M, Levy M, Laterre PF. Rationale and protocol for the efficacy, safety and tolerability of nangibotide in patients with septic shock (ASTONISH) phase IIb randomised controlled trial. BMJ Open. 2021 Jul 7;11(7):e042921. doi: 10.1136/bmjopen-2020-042921.
Other Identifiers
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2018-004827-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MOT-C-203
Identifier Type: -
Identifier Source: org_study_id
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