The Role of TLR-4 Polymorphisms in Children With Urinary Track Infections

NCT02021305 | Unknown

• 1 other identifier: 230283
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose So far anatomical abnormalities (mostly congenital) were, in the majority of the patients, associated with urinary track infections. In this study the researchers will try to investigate the role of TLRs as molecular interactions between bacterial virulence and host response. TLRs are important mediators in the development of the natural immunity against bacteria. They recognize microbial pathogen associated molecular patterns and alert the host's immune system to the presence of invading microbes

Conditions

Urinary Tract Infection

Keywords

Toll like Receptors; TLR 4; Urinary track infections in children; TLR 4 polymorphisms; Innate immunity; Defence mechanisms; Immune responses

Outcome Measures

Primary Outcomes (1)

• frequency of TLR-4 299, 399 polymorphism and expression of TLR-2 and TLR-4 by monocytes in children with urinary track infection and healthy controls.

  4 years

Study Arms (2)

Patients

60 children with a recorded episode of acute Urinary Track infection who attended 4th Department of Pediatrics of Medical School of Aristotle University of Thessaloniki.

Controls

100 children with no history of Urinary Track Infection who attended 4th Department of Pediatrics of Medical School of Aristotle University of Thessaloniki.

Eligibility Criteria

• Age: 6 Months - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients an controls are selected from the Emergency Department and Outpatient Clinics of the 4th Department of Pediatrics , Aristotle University of Thessaloniki, Papageorgiou Hospital, Thessaloniki, Greece

You may qualify if:

• For the patients
• months -14 years of age
• unrelated male and female children with one episode of acute urinary track infection (positive urine culture and clinical symptoms )
• with/without anatomic genitourinary anomalies .
• children with upper UTI or children with lower UTI
• Sign written informed consent
• For the controls
• months-14 years of age
• age and gender matched with the patients
• unrelated male and female children with no recorded history of urinary track infection and negative urine cultures .
• Sign written informed consent

You may not qualify if:

• For the patients
• Subjects who do not meet the criteria above
• Severe or chronic illness
• Symptoms of acute infection
• Immune deficiency or immune suppressor therapy
• Medication
• For the controls
• Subjects who do not meet the criteria above
• Severe or chronic illness
• Symptoms of acute infection
• Immune deficiency or immune suppressor therapy
• Medication

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Thessaloniki, 54603, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Efimia Papadopoulou-Alataki, MD, PhD

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Efimia Papadopoulou-Alataki, MD, PhD

CONTACT

+302313323901; efiala@otenet.gr

Panagiota Karananou, MD

CONTACT

+302313323901; yiotar@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2017
• Last Updated: December 27, 2013

Record last verified: 2013-12

Locations

GR (1)