Bacterial Infections Clinical Trial
Official title:
Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels in Infants Under 1 Year of Age Suspected of Systemic Bacterial Infection
| NCT number | NCT06354205 |
| Other study ID # | 24-3.1T/98 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 1, 2024 |
| Est. completion date | April 1, 2025 |
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.
| Status | Recruiting |
| Enrollment | 160 |
| Est. completion date | April 1, 2025 |
| Est. primary completion date | March 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Years to 1 Year |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Ege University School of Medicine | Izmir |
| Lead Sponsor | Collaborator |
|---|---|
| Ege University | THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKIYE |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation | the correlation between serum Procalcitonin (PCT) levels and salivary PCT levels | One year | |
| Secondary | Diagnose | Diagnostic value of saliva PCT | One year |
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