AzTrials
AzTrials

Intra Abdominal InfectionsNCT07689266

Soluble Immune Checkpoints in Intra-Abdominal Infections

An observational study of Intra Abdominal Infections, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Intra Abdominal Infections
What is being tested?
Soluble Immune checkpoint levels
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2023to 1 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with intraabdominal infections due to gastrointestinal pathologies

Who may be able to join

  • Patients with intraabdominal infections due to gastrointestinal pathologies

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Training and Research Hospital

    Istanbul, 34098

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Soluble Immune checkpoint levels
Keywords
Intestinal Perforation, Sepsis, Immune checkpoints
Medical subject headings
Intraabdominal Infections, Intestinal Perforation, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soluble Immune checkpoint levelsDiagnostic test

    Soluble Immune checkpoint levels of the groups before any treatments

Study groups in NCT07689266
Study groupRoleWhat they receive
Severe Intraabdominal InfectionSevere Intraabdominal Infection patients with qSOFA 2 and 3
Receives: Diagnostic Test: Soluble Immune checkpoint levels
Mild Intraabdominal InfectionMild Intraabdominal Infection patients with qSOFA 0 and 1
Receives: Diagnostic Test: Soluble Immune checkpoint levels
ControlHealthy Volunteers without intraabdominal infection
Receives: Diagnostic Test: Soluble Immune checkpoint levels

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: December 2023- December 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2024
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07689266
Sponsor's protocol ID
Intraabdominal Infections
Status last verified
Jul 2026
First submitted
1 Jul 2026
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35230752
  • 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.

    PubMed 33494007
  • 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.

    PubMed 41225969

Questions about this trial

What is this clinical trial studying?

An observational study of Intra Abdominal Infections, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Soluble Immune checkpoint levels (time frame: December 2023- December 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07689266, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in