Evidence map›Paper›PMID 32468087›Full record

Trial reportIntensive care medicine2020

Nangibotide in patients with septic shock: a Phase 2a randomized controlled clinical trial.

Bruno François, Xavier Wittebole, Ricard Ferrer, Jean-Paul Mira, Thierry Dugernier, Sébastien Gibot, Marc Derive, Aurélie Olivier, Valérie Cuvier, Stephan Witte and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Intensive care medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07176741 (Measurement of Hepatocyte TREM-1 Expression Level to Evaluate Its Intrinsic Performance and Prognostic Value in Severe Symptomatic Alcohol-related Hepatitis), which is not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07176741 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Measurement of Hepatocyte TREM-1 Expression Level to Evaluate Its Intrinsic Performance and Prognostic Value in Severe Symptomatic Alcohol-related Hepatitis

TypeobservationalSponsorCentral Hospital, Nancy, FranceRan2025 to 2026Enrolled300ConditionsSevere Alcoholic HepatitisArmsTREM-1 expression (via immunohistochemistry) between SAH patients and controls
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Biomarkers in lower respiratory tract samples in the diagnosis of ventilator-associated pneumonia: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
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  13. Anti-DAMP therapies for acute inflammation.Frontiers in immunology · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 5 countries.

Bruno FrançoisMedical-Surgical ICU Department and Inserm CIC1435 & UMR1092, CRICS-TRIGGERSEP Network, CHU Limoges, Limoges, France. b.francois@unilim.fr.ORCID http://orcid.org/0000-0002-2531-1652
Xavier WitteboleDepartment of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.
Ricard FerrerICU Department, Vall d'Hebron University Hospital, Barcelona, Spain.
Jean-Paul MiraMedical ICU, Cochin Hotel-Dieu, AP-HP, Paris, France.
Thierry DugernierICU Department, Clinique St. Pierre, Ottignies, Belgium.
Sébastien GibotMedical ICU Department, Hospital Central, CHU Nancy, Nancy, France.
Marc DeriveInotrem SA, Paris, France.
Aurélie OlivierInotrem SA, Paris, France.
Valérie CuvierInotrem SA, Paris, France.
Stephan WitteHelion Pharma, Schriesheim, Germany.
Peter PickkersICU Department, Radboudumc Hospital, Nijmegen, The Netherlands.
François VandenhendeClinBay SPRL, Baisy-Thy, Belgium.
Jean-Jacques GaraudInotrem SA, Paris, France.
Miguel SánchezICU Department, Hospital Clínico San Carlos, Madrid, Spain.
Margarita Salcedo-MagguilliInotrem SA, Paris, France.
Pierre-François LaterreDepartment of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.
Inserm · FRUCLouvain · BEAssistance Publique – Hôpitaux de Paris · FRClinique Saint Pierre · BEHospital Clínico San Carlos · ESMerLion Pharma (Germany) · DERadboud University Nijmegen · NLVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNangibotide is a specific TREM-1 inhibitor that tempered deleterious host-pathogens interactions, restored vascular function, and improved survival, in animal septic shock models. This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients.

methodsThis was a multicenter randomized, double-blind, two-stage study. Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days. Safety primary outcomes were adverse events (AEs), whether serious or not, and death. Exploratory endpoints evaluated nangibotide effects on pharmacodynamics, organ function, and mortality, and were analyzed according to baseline sTREM-1 concentrations.

resultsForty-nine patients were randomized. All treatment emergent AEs (TEAEs) were collected until Day 28. No significant differences were observed in TEAEs between treatment groups. No drug withdrawal linked to TEAE nor appearance of anti-drug antibodies were reported. Nangibotide pharmacokinetics appeared to be dose-proportional and clearance was dose-independent. Nangibotide did not significantly affect pharmacodynamic markers. Decrease in SOFA score LS mean change (± SE) from baseline to Day 5 in pooled nangibotide groups versus placebo was - 0.7 (± 0.85) in the randomized population and - 1.5 (± 1.12) in patients with high baseline plasma sTREM-1 concentrations (non-significant). This pattern was similar to organ support end points.

conclusionNo significant increases in TEAEs were detected in nangibotide-treated patients versus placebo. These results encourage further evaluation of nangibotide and further exploration of plasma sTREM-1 concentrations as a predictive efficacy biomarker.

Indexed as

Shock, SepticAnimalsDouble-Blind MethodHumansImmunologic FactorsTreatment OutcomeImmunologic FactorsLR12NangibotideSeptic shockTREM-1

Identifiers

PMID32468087
OpenAlexW3032719613

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.