NCT07689266

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 1, 2026

Last Update Submit

July 1, 2026

Conditions

Intra Abdominal Infections

Keywords

Intestinal PerforationSepsisImmune checkpoints

Outcome Measures

Primary Outcomes (1)

  • Soluble Immune checkpoint levels

    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

Study Arms (3)

Severe Intraabdominal Infection

Severe Intraabdominal Infection patients with qSOFA 2 and 3

Diagnostic Test: Soluble Immune checkpoint levels

Mild Intraabdominal Infection

Mild Intraabdominal Infection patients with qSOFA 0 and 1

Diagnostic Test: Soluble Immune checkpoint levels

Control

Healthy Volunteers without intraabdominal infection

Diagnostic Test: Soluble Immune checkpoint levels

Interventions

Soluble Immune checkpoint levelsDIAGNOSTIC_TEST

Soluble Immune checkpoint levels of the groups before any treatments

ControlMild Intraabdominal InfectionSevere Intraabdominal Infection

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with intraabdominal infections due to gastrointestinal pathologies

You may qualify if:

  • Patients with intraabdominal infections due to gastrointestinal pathologies

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (3)

  • Huang CM, Xu XJ, Qi WQ, Ge QM. Prognostic significance of soluble CD25 in patients with sepsis: a prospective observational study. Clin Chem Lab Med. 2022 Feb 28;60(6):952-958. doi: 10.1515/cclm-2022-0068. Print 2022 May 25.

    PMID: 35230752BACKGROUND

  • Moar P, Tandon R. Galectin-9 as a biomarker of disease severity. Cell Immunol. 2021 Mar;361:104287. doi: 10.1016/j.cellimm.2021.104287. Epub 2021 Jan 14.

    PMID: 33494007BACKGROUND

  • Kim U, Lee S, Han KS, Kim SJ, Lee S, Park DW, Song J. Clinical Value of Galectin-9, Soluble TREM-1, and Soluble CD25 Among Critically Ill Patients with Organ Failure in the Emergency Department: A Prospective Observational Study. Diagnostics (Basel). 2025 Oct 23;15(21):2677. doi: 10.3390/diagnostics15212677.

    PMID: 41225969BACKGROUND

MeSH Terms

Conditions

Intraabdominal InfectionsIntestinal PerforationSepsis

Condition Hierarchy (Ancestors)

InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. MD. PhD

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

December 1, 2023

Primary Completion

December 31, 2024

Study Completion

August 1, 2025

Last Updated

July 8, 2026

Record last verified: 2026-07

Locations

TU(1)