Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels

NCT ID: NCT06354205

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.

The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections Children, Only Procalcitonin Saliva

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients selection

Children under 1 year of age will be recruited for saliva and blood sample collection in the study

Group Type OTHER

Sliva Procalcitonin

Intervention Type DIAGNOSTIC_TEST

Sliva Procalcitonin vs Blood procalcitonin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sliva Procalcitonin

Sliva Procalcitonin vs Blood procalcitonin

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being under one year of age
* Having serum Procalcitonin (PCT) requested due to suspicion of systemic infection

Exclusion Criteria

* Being over one year of age
* Having a chronic illness that could cause elevation in inflammatory biomarkers
* Taking any medication (such as antibiotics, immunomodulatory, or immunosuppressive drugs, etc.) that could affect inflammatory biomarkers
* Diagnosis of gingivostomatitis
Minimum Eligible Age

0 Years

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Ege University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Caner Turan

Caner Turan

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ege University School of Medicine

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Caner Turan, PhD

Role: CONTACT

+902323901510

Sercan Cinarli

Role: CONTACT

+902323901001

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Caner Turan

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24-3.1T/98

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Group A Streptococcus Saliva Study
NCT06473506 ACTIVE_NOT_RECRUITING NA