Ignite Creation Date:
2025-12-25 @ 3:36 AM
Ignite Modification Date:
2026-03-11 @ 11:06 PM
Study NCT ID:
NCT02021305
Status:
UNKNOWN
Last Update Posted:
2013-12-27
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of TLR-4 Polymorphisms in Children With Urinary Track Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-20', 'studyFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Toll like Receptors', 'TLR 4', 'Urinary track infections in children', 'TLR 4 polymorphisms', 'Innate immunity', 'Defence mechanisms', 'Immune responses'], 'conditions': ['Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': "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.\n\nTLRs 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", 'detailedDescription': 'The aim of his observational case-control study is to :\n\n1. investigate if the expression of TLR2 and TLR4 mediate in the development of the natural immunity of the uroepithileal cells against bacteria.\n2. evaluate the effect of the TLR-gene Asp299Gly and Thr399Ile polymorphisms on the development and clinical severity of urinary tract infections (UTI) in children.\n3. determine the association of the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms with the formation of renal scar in children.\n4. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the patients\n\n * 6months -14 years of age\n * unrelated male and female children with one episode of acute urinary track infection (positive urine culture and clinical symptoms )\n * with/without anatomic genitourinary anomalies .\n * children with upper UTI or children with lower UTI\n * Sign written informed consent\n\nInclusion Criteria:\n\nFor the controls\n\n* 6 months-14 years of age\n* age and gender matched with the patients\n* unrelated male and female children with no recorded history of urinary track infection and negative urine cultures .\n* Sign written informed consent\n\nExclusion Criteria:\n\n* For the patients\n\n * Subjects who do not meet the criteria above\n * Severe or chronic illness\n * Symptoms of acute infection\n * Immune deficiency or immune suppressor therapy\n * Medication\n\nExclusion Criteria:\n\nFor the controls\n\n* Subjects who do not meet the criteria above\n* Severe or chronic illness\n* Symptoms of acute infection\n* Immune deficiency or immune suppressor therapy\n* Medication'}, 'identificationModule': {'nctId': 'NCT02021305', 'acronym': 'TLR-4', 'briefTitle': 'The Role of TLR-4 Polymorphisms in Children With Urinary Track Infections', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'The Role of TLR-4 Asp299Gly and Thr399Ile Polymorphisms in Children With Urinary Tack Infections', 'orgStudyIdInfo': {'id': '230283'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '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.'}, {'label': 'Controls', 'description': '100 children with no history of Urinary Track Infection who attended 4th Department of Pediatrics of Medical School of Aristotle University of Thessaloniki.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54603', 'city': 'Thessaloniki', 'state': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Efimia Papadopoulou-Alataki, MD, PhD', 'role': 'CONTACT', 'email': 'efiala@otenet.gr', 'phone': '+302313323901'}, {'name': 'Panagiota Karananou, MD', 'role': 'CONTACT', 'email': 'yiotar@hotmail.com', 'phone': '+302313323901'}], 'facility': 'Aristotle University of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Efimia Papadopoulou-Alataki, MD, PhD', 'role': 'CONTACT', 'email': 'efiala@otenet.gr', 'phone': '+302313323901', 'phoneExt': '0030'}, {'name': 'Panagiota Karananou, MD', 'role': 'CONTACT', 'email': 'yiotar@hotmail.com', 'phone': '+302313323901', 'phoneExt': '0030'}], 'overallOfficials': [{'name': 'Efimia Papadopoulou-Alataki, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Panagiota Karananou', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}