Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT07301294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069349', 'term': 'Linezolid'}, {'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biofilm bacterial load', 'timeFrame': '1 month', 'description': 'Biofilm bacterial load, defined as the quantity of bacteria within a biofilm, measured by culture of a swab taken off Double J stent after removal and expressed in numbers.'}], 'secondaryOutcomes': [{'measure': 'Urinary tract infection rate', 'timeFrame': '1 month', 'description': 'urinary tract infection, defined as presence of positive urine culture after double J stent insertion, expressed in numbers.'}, {'measure': 'Double J related symptoms', 'timeFrame': '1 month', 'description': 'Double J related symptoms, defined as lower urinary tract symptoms that patient expeirence after double J stent insertion, measured using the ureteral stent symptom questionnaire (USSQ), expressed in numbers.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DJ stent', 'Double J stent', 'ureteric stent', 'Biofilm', 'Mucolytic', 'Linezolid'], 'conditions': ['Double J Stent']}, 'descriptionModule': {'briefSummary': 'Indwelling Double J (DJ) ureteral stents are commonly used following lithotripsy to ensure adequate urinary drainage and prevent obstruction. However, stent-related biofilm formation remains a significant clinical problem, contributing to infection, encrustation, patient discomfort, and stent failure. Biofilms consist of microbial communities embedded within an extracellular polymeric substance (EPS), which protects microorganisms from host defenses and antimicrobial agents.\n\nAntibiotic therapy alone may be insufficient to eradicate established biofilms due to poor penetration into the EPS matrix. Linezolid is a potent antibiotic with activity against gram-positive organisms commonly implicated in urinary tract colonization and penetrate and effectively act against bacterial biofilms. Mucolytic agents, by disrupting the biofilm matrix, may enhance antimicrobial penetration and reduce biofilm burden.\n\nThe combination of an antibiotic with a mucolytic agent may therefore provide superior biofilm reduction compared to either approach alone or no treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Adult patients (≥18 years).\n* Undergoing lithotripsy (FURS, URS or PCNL) with DJ stent insertion.\n* Stone free status.\n* Planned stent indwelling time of 1 month.\n* Negative preoperative urine culture.\n\nExclusion Criteria\n\n* Known allergy or contraindication to linezolid or the selected mucolytic agent.\n* Chronic kidney disease.\n* Immunocompromised patients (e.g., chemotherapy, long-term steroid use).\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT07301294', 'briefTitle': 'Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Biofilm of DJ stent'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients of this group will receive no medications'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic group', 'description': 'Patients of this group will receive Linezolid.', 'interventionNames': ['Drug: Linezolid (LZD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mucolytic group', 'description': 'Patients of this group will receive N-Acetylcysteine.', 'interventionNames': ['Drug: N-Acetyl Cysteine (NAC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combination group', 'description': 'Patients of this group will receive both Linezolid and N-Acetylcysteine.', 'interventionNames': ['Drug: Linezolid (LZD)', 'Drug: N-Acetyl Cysteine (NAC)']}], 'interventions': [{'name': 'Linezolid (LZD)', 'type': 'DRUG', 'description': 'Linezolid 600 mg, oral, twice daily, for 7 days.', 'armGroupLabels': ['Antibiotic group', 'Combination group']}, {'name': 'N-Acetyl Cysteine (NAC)', 'type': 'DRUG', 'description': 'N-Acetyl cysteine 600 mg, oral, once daily, for 30 days.', 'armGroupLabels': ['Combination group', 'Mucolytic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Shebin El-Kom', 'state': 'Menoufia', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Aziz', 'role': 'CONTACT', 'email': 'Mohammed_aziz2006@yahoo.com', 'phone': '+201023321949'}], 'facility': 'Menoufia Faculty of Medicine'}], 'centralContacts': [{'name': 'Ammar Alorabi', 'role': 'CONTACT', 'email': 'ammar.alorabi95@gmail.com', 'phone': '+201067608011'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ammar Fathi Mohamed AlOrabi', 'investigatorAffiliation': 'Menoufia University'}}}}