Comparing saliva and blood tests for bacterial infections in children
Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels in Infants Under 1 Year of Age Suspected of Systemic Bacterial Infection
NA · Ege University · NCT06354205
This study is testing if saliva tests can effectively diagnose bacterial infections in babies under one year old, instead of using blood tests.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 0 Years to 1 Year |
| Sex | All |
| Sponsor | Ege University (other) |
| Locations | 1 site (İzmir) |
| Trial ID | NCT06354205 on ClinicalTrials.gov |
What this trial studies
This study evaluates the correlation between procalcitonin (PCT) levels in saliva and serum in children suspected of having systemic bacterial infections. It aims to determine whether saliva can serve as a non-invasive diagnostic tool, potentially replacing blood tests. The research focuses on children under one year of age, who are suspected of having a systemic infection, and will analyze the effectiveness of saliva PCT levels in diagnosing these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are children under one year of age with suspected systemic infections requiring serum procalcitonin testing.
Not a fit: Patients over one year of age or those with chronic illnesses affecting inflammatory biomarkers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible method for diagnosing bacterial infections in young children.
How similar studies have performed: While there have been animal studies suggesting the use of saliva PCT levels for certain conditions, this approach in humans for systemic infections is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
İzmir
- Ege University School of Medicine — İzmir, Turkey (RECRUITING)
Study contacts
- Study coordinator: Caner Turan, PhD
- Email: drcanerturan@gmail.com
- Phone: +902323901510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bacterial Infections, Children, Only, Procalcitonin, Saliva, procalcitonin, saliva, children, infection