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).
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
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.
- Conditions
- Intra Abdominal Infections
- 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 group | Role | What they receive |
|---|---|---|
| Severe Intraabdominal Infection | Severe Intraabdominal Infection patients with qSOFA 2 and 3 Receives: Diagnostic Test: Soluble Immune checkpoint levels | |
| Mild Intraabdominal Infection | Mild Intraabdominal Infection patients with qSOFA 0 and 1 Receives: Diagnostic Test: Soluble Immune checkpoint levels | |
| Control | Healthy 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.
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.
- First posted8 Jul 2026
- Study start1 Dec 2023
- Primary completion31 Dec 2024
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intra Abdominal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Istanbul Training and Research Hospital
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 35230752Moar 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 33494007Kim 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Soluble Immune Checkpoint Molecules in Intra-abdominal Infection: Association With Disease Severity and Mortality
- ClinicalTrials.gov ID
- NCT07689266
- Acronym / sponsor ID
- Intraabdominal Infections
- Conditions
- Intra Abdominal Infections
- Keywords
- Intestinal Perforation, Sepsis, Immune checkpoints
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe Intraabdominal Infection | – | Diagnostic Test: Soluble Immune checkpoint levelsSevere Intraabdominal Infection patients with qSOFA 2 and 3 |
| Mild Intraabdominal Infection | – | Diagnostic Test: Soluble Immune checkpoint levelsMild Intraabdominal Infection patients with qSOFA 0 and 1 |
| Control | – | Diagnostic Test: Soluble Immune checkpoint levelsHealthy Volunteers without intraabdominal infection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intraabdominal infections due to gastrointestinal pathologies
Key inclusion criteria (1 listed)
- Patients with intraabdominal infections due to gastrointestinal pathologies
Key exclusion criteria (4 listed)
- Malignities
- Pregnancy
- Immune deficiency
- Patients without intraabdominal infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble Immune checkpoint levelsSoluble Immune checkpoint levels of the groups before any treatments | Diagnostic test | Control, Mild Intraabdominal Infection, Severe Intraabdominal Infection |
Primary outcome
Soluble Immune checkpoint levels
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 35230752Huang 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.
- Background: PubMed 33494007Moar 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.
- Background: PubMed 41225969Kim 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.
- Individual participant dataSharing planned: Undecided
Related trials for Intra Abdominal Infections
RecruitingPhase 2
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Gram-negative Bacterial Infections
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
RecruitingObservational study
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection
RecruitingObservational study
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.