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

NCT06354205 | Recruiting

• 1 other identifier: 24-3.1T/98
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Infections; Children, Only; Procalcitonin; Saliva

Keywords

procalcitonin; saliva; children; infection

Outcome Measures

Primary Outcomes (1)

• Correlation

  the correlation between serum Procalcitonin (PCT) levels and salivary PCT levels

  One year

Secondary Outcomes (1)

• Diagnose

  One year

Study Arms (1)

Patients selection

OTHER

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

Diagnostic Test: Sliva Procalcitonin

Interventions

Sliva Procalcitonin DIAGNOSTIC_TEST

Sliva Procalcitonin vs Blood procalcitonin

Patients selection

Eligibility Criteria

• Age: 0 Years - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ege University School of Medicine

Izmir, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bacterial Infections; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Central Study Contacts

Caner Turan, PhD

CONTACT

+902323901510; drcanerturan@gmail.com

Sercan Cinarli

CONTACT

+902323901001; sercancinarli4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Caner Turan

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)