CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 276 enrolled
Drug / intervention
The Leukocyte ImmunoTest™ (LIT™)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05968287
NCT05968287N/ACompleted

Evaluation of the Relationship of Neutrophil Functions With Sepsis and Septic Shock Using the Leukocyte ImmunoTest™ in Patients With Various Infectious Conditions

Gazi University·observational·Posted Aug 1, 2023·Updated Aug 1, 2023

In Brief

An observational study evaluating The Leukocyte ImmunoTest™ (LIT™) for Infections and 2 related conditions. Completed, enrolled 276 participants across 1 site.

Detailed Summary

Neutrophils are indispensable for host defense and have an important roles in modulating the immune system in both the innate and adaptive immune response. Neutrophils operate using a number of different mechanisms including chemotaxis, phagocytosis, release of reactive oxygen species (ROS) and granular proteins, and the production and liberation of cytokines for this purpose. A controlled neutrophil response is required to combat infection; an dysregulated state of this response can cause sepsis, tissue damage, and organ failure. Sepsis and septic shock are the leading causes of death especially in intensive care units (ICU), and their mortality can be reduced with prompt diagnosis and appropriate treatment modality. From this point of view, many biomarkers have been evaluated for the diagnosis, prognosis, and treatment response of infection and sepsis. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in detecting and monitoring changes related to infection status and to determine development of sepsis and positive effects of interventions.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
CollaboratorsSeroxo Ltd

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 1, 2023
Enrollment StartJun 28, 2022
Primary CompletionJan 27, 2023
Study CompletionJan 31, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.9 years ago

Interventions

The Leukocyte ImmunoTest™ (LIT™)other

The baseline LIT scores was performed for two parallel groups. The sequential LIT score was also performed for patients with various infection conditions with/without sepsis.