Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Soluble Immune Checkpoints in Intra-Abdominal Infections

1 juli 2026 bijgewerkt door: Ufuk Oguz Idiz, Istanbul Training and Research Hospital

Serum Soluble Immune Checkpoint Molecules in Intra-abdominal Infection: Association With Disease Severity and Mortality

Intraabdominal infections is a life-threatening syndrome with a high incidence and a significant economic burden. The early-stage cytokine storm and the late-stage immunosuppression contribute to the mortality of sepsis. Immune checkpoints expressed on lymphocytes and antigen-presenting cells (APCs) play a crucial role in the pathogenesis of sepsis by regulating immune dysfunction. Specific therapies targeting immune checkpoints have shown great potential in animal and preclinical studies, paving the way for further clinical research. In this study, the significance of serum immune checkpoints - sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-beta1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, and Galectin-9 - will be investigated in patients with intraabdominal infection.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

The abdominal region is the second most common source of sepsis and secondary peritonitis. The most frequent causes of abdominal infections are perforation, ischemic necrosis, or penetrating injuries to intra-abdominal organs. Management consists of infection source control, restoration of gastrointestinal (GI) function, systemic antimicrobial therapy, and support of organ function. Despite advances in care, mortality following secondary peritonitis remains high. Excluding patient-related factors such as age or comorbidities that cannot be influenced during intervention, delays in surgical intervention and failure to achieve source control are the main determinants of outcomes.

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection and accounted for approximately 11 million deaths worldwide in 2017, representing 19.7% of all global deaths. Early deaths in sepsis are typically due to septic shock caused by a cytokine storm. In contrast, late deaths result from the inability to clear primary infections and the development of secondary infections due to a state of immunosuppression.

Multiple mechanisms contribute to immune dysfunction in sepsis. Immune checkpoints, which assist in T cell activation, play critical roles in this process. Immune checkpoint molecules expressed on lymphocytes and antigen-presenting cells (APCs) - including CD28, cytotoxic T-lymphocyte antigen 4 (CTLA-4), CD80, CD86, programmed death-1 (PD-1), and programmed death-ligand 1 (PD-L1) - as well as CD40 and CD40L, OX40 and OX40L, 4-1BB and 4-1BBL, B and T lymphocyte attenuator (BTLA), and the T cell immunoglobulin mucin (Tim) family, serve as co-signaling molecules for T cell activation and immune regulation. Immune checkpoints exert a dual effect on the host response during sepsis. On one hand, during pathogen invasion, immune checkpoints provide critical secondary signals that help APCs activate T cells. Activated T cells and APCs create a positive feedback loop, triggering the cytokine storm. On the other hand, immune checkpoints also regulate T cell activation and inhibition in the late phase of sepsis, leading to T cell anergy and apoptosis.

CTLA-4, also known as CD152, is a competitive receptor for CD28 and plays a negative regulatory role in the immune response of inflammatory diseases by modulating CD28-mediated T cell costimulation. CTLA-4 is also expressed on T regulatory (Treg) cells and temporarily blocks their immune effects. Anti-CTLA-4-based immunotherapy has shown a dose-dependent effect in reducing sepsis-induced apoptosis in a cecal ligation and puncture (CLP) mouse model of sepsis. However, it has minimal effects on inflammatory cytokines.

PD-1, an inhibitory receptor of the CD28 family, is mainly expressed on lymphocytes, dendritic cells (DCs), monocytes, and macrophages. PD-L1, another member of the B7 family and the primary ligand of PD-1, can also be found on lymphocytes, DCs, monocytes, and macrophages. PD-1 and PD-L1 play critical roles in the immunosuppressive state of sepsis and may serve as valuable tools for assessing immune status and as potential therapeutic targets in sepsis. Various studies have confirmed that PD-1, PD-L1, and PD-L2 expression on monocytes and T lymphocytes is increased in septic patients, contributing to a novel immune regulatory system involved in immune dysfunction during sepsis. PD-1 expression on monocytes and T cell repertoire diversity have shown a positive correlation with serum interleukin levels and have been predictive of mortality in patients with septic shock. PD-L1 expression on neutrophils and monocytes has also been associated with risk stratification and mortality in septic patients.

For these reasons, elucidating the roles of immune checkpoints in the pathogenesis of sepsis and the use of immunotherapy hold great potential for sepsis treatment. Although there are limited studies in the literature on the expression of PD-1, PD-L1, PD-L2, and CTLA-4 on T cells and monocytes in sepsis patients, no studies have focused on these markers specifically in intra-abdominal infection patients or on their soluble forms in serum.

Studietype

Observationeel

Inschrijving (Werkelijk)

75

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Istanbul, Turkije (Türkiye), 34098
        • Istanbul Training and Research Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with intraabdominal infections due to gastrointestinal pathologies

Beschrijving

Inclusion Criteria:

  • Patients with intraabdominal infections due to gastrointestinal pathologies

Exclusion Criteria:

  • Malignities
  • Pregnancy
  • Immune deficiency
  • Patients without intraabdominal infections

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Severe Intraabdominal Infection
Severe Intraabdominal Infection patients with qSOFA 2 and 3
Soluble Immune checkpoint levels of the groups before any treatments
Mild Intraabdominal Infection
Mild Intraabdominal Infection patients with qSOFA 0 and 1
Soluble Immune checkpoint levels of the groups before any treatments
Control
Healthy Volunteers without intraabdominal infection
Soluble Immune checkpoint levels of the groups before any treatments

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Soluble Immune checkpoint levels
Tijdsspanne: December 2023- December 2024
sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9
December 2023- December 2024

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2023

Primaire voltooiing (Werkelijk)

31 december 2024

Studie voltooiing (Werkelijk)

1 augustus 2025

Studieregistratiedata

Eerst ingediend

1 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juli 2026

Eerst geplaatst (Werkelijk)

8 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren