COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021305
Recruitment Status : Unknown
Verified December 2013 by Panagiota Karananou, Aristotle University Of Thessaloniki.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Panagiota Karananou, Aristotle University Of Thessaloniki

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease
Urinary Tract Infection

Detailed Description:

The aim of his observational case-control study is to :

  1. investigate if the expression of TLR2 and TLR4 mediate in the development of the natural immunity of the uroepithileal cells against bacteria.
  2. evaluate the effect of the TLR-gene Asp299Gly and Thr399Ile polymorphisms on the development and clinical severity of urinary tract infections (UTI) in children.
  3. determine the association of the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms with the formation of renal scar in children.
  4. investigate the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms in healthy children and elaborate the results to the possible carriers of these polymorphisms.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of TLR-4 Asp299Gly and Thr399Ile Polymorphisms in Children With Urinary Tack Infections
Study Start Date : February 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2017
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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. [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
Whole Blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • For the patients

    • 6months -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

Inclusion Criteria:

For the controls

  • 6 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

Exclusion Criteria:

  • 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

Exclusion Criteria:

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021305


Contacts
Layout table for location contacts
Contact: Efimia Papadopoulou-Alataki, MD, PhD +302313323901 ext 0030 efiala@otenet.gr
Contact: Panagiota Karananou, MD +302313323901 ext 0030 yiotar@hotmail.com

Locations
Layout table for location information
Greece
Aristotle University of Thessaloniki Recruiting
Thessaloniki, Greece, 54603
Contact: Efimia Papadopoulou-Alataki, MD, PhD    +302313323901    efiala@otenet.gr   
Contact: Panagiota Karananou, MD    +302313323901    yiotar@hotmail.com   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Layout table for investigator information
Study Director: Efimia Papadopoulou-Alataki, MD, PhD Aristotle University Of Thessaloniki
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Panagiota Karananou, MD, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02021305    
Other Study ID Numbers: 230283
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: December 2013
Keywords provided by Panagiota Karananou, Aristotle University Of Thessaloniki:
Toll like Receptors
TLR 4
Urinary track infections in children
TLR 4 polymorphisms
 Innate immunity
Defence mechanisms
Immune responses
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases