The Role of TLR-4 Polymorphisms in Children With Urinary... | NCT02021305

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

NCT02021305

Sponsor

Aristotle University Of Thessaloniki

Status

Unknown status

Last Update Posted

Dec 27, 2013Estimated

Enrollment

160Estimated

Phase

Not provided

Conditions

Urinary Tract Infection

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Feb 2014Estimated

Completion Date

Feb 2017Estimated

First Submitted Date

Dec 20, 2013

First Submission Date that Met QC Criteria

Dec 20, 2013

First Posted Date

Dec 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2013

Last Update Posted Date

Dec 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

investigate if the expression of TLR2 and TLR4 mediate in the development of the natural immunity of the uroepithileal cells against bacteria.
evaluate the effect of the TLR-gene Asp299Gly and Thr399Ile polymorphisms on the development and clinical severity of urinary tract infections (UTI) in children.
determine the association of the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms with the formation of renal scar in children.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

14 Years

Standard Ages

Child

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Efimia Papadopoulou-Alataki, MD, PhD	Contact	+302313323901	0030	efiala@otenet.gr
Panagiota Karananou, MD	Contact	+302313323901	0030	yiotar@hotmail.com

Overall Officials

Name	Affiliation	Role
Efimia Papadopoulou-Alataki, MD, PhD	Aristotle University Of Thessaloniki	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aristotle University of Thessaloniki	Recruiting	Thessaloniki	Thessaloniki	54603	Greece

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications