Status:
COMPLETED
The Association of Gene Polymorphisms With Invasive Bacterial Infections in Neonates and Young Infants
Lead Sponsor:
Ege University
Conditions:
Polymorphism, Genetic
Bacterial Infections
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
Invasive bacterial infections (IBIs) are globally significant, with high mortality rates, particularly within the critical 0-3 month age bracket. The first three months of life mark a peak in IBI prev...
Detailed Description
We conducted a prospective observational study at a leading tertiary care hospital in Turkey. The cohort included 100 infants aged 0-3 months diagnosed with IBIs alongside 100 control infants presenti...
Eligibility Criteria
Inclusion
- Infants aged between 1 day and 90 days (under 3 months)
- Hospitalized for evaluation of suspected invasive bacterial infections
- Informed consent obtained from parent(s) or legal guardian(s)
- Blood, urine, cerebrospinal fluid (CSF), or stool samples collected within 72 hours of admission
- Genetic material (blood sample) available for DNA extraction
Exclusion
- Known or suspected congenital immunodeficiency
- Previous diagnosis of genetic syndromes affecting immune function
- Major congenital anomalies or chromosomal abnormalities
- Antibiotic therapy initiated more than 24 hours before sample collection
- Parental refusal to participate or withdraw consent
Key Trial Info
Start Date :
April 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06985160
Start Date
April 25 2020
End Date
March 15 2024
Last Update
May 22 2025
Active Locations (2)
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1
Ege University School of Medicine
Izmir, İzmir, Turkey (Türkiye), 35100
2
Ege University School of Medicine
Izmir, Turkey (Türkiye)