Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT07116356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Characterization of Carbapenemase-Producing Enterobacterales
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isolation of causative organism', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Antibitic sensitivity test:', 'timeFrame': '2 months'}, {'measure': 'Molecular detection of carbapenem resistant genes:', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbapenem', 'enterobacterials,', 'Antibitic sensitivity', 'PCR'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://dx.doi.org/10.4103/ecdt.ecdt_40_23', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Bacterial infections with carbapenem resistant pathogens are one of the major threats in immunocompromised patients, especially among cancer patients .Furthermore, Gram negative pathogens are becoming increasingly prevalent and have become an ongoing global health concern .Emergence of Gram-negative pathogens, especially Enterobacterales that avert many of the human defense mechanisms are alarmingly increasing and most of these pathogens are resistant to many of the in-use antibiotics including carbapenems .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to Sohag Oncology Center have different infections and isolated organism one of carbapenem resistant enterobacterales detected by antibiotic sensitivity test.\n\nExclusion Criteria:\n\n* All patients admitted to Sohag Oncology Center having infections in different sites and isolated organisms are not one of enterobacterales and not carbapenem resistant.'}, 'identificationModule': {'nctId': 'NCT07116356', 'briefTitle': 'Molecular Characterization of Carbapenemase-Producing Enterobacterales', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Molecular Characterization of Carbapenemase-Producing Enterobacterales Isolated From Clinical Samples in Egypt', 'orgStudyIdInfo': {'id': 'Soh-Mmed-25-7-10PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 Patients with enterobacterials infections', 'interventionNames': ['Diagnostic Test: Antibiotic administration', 'Diagnostic Test: Molecular detection of antibiotic resistance']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 patients with other bacterial infections', 'interventionNames': ['Diagnostic Test: Antibiotic administration', 'Diagnostic Test: Molecular detection of antibiotic resistance']}], 'interventions': [{'name': 'Antibiotic administration', 'type': 'DIAGNOSTIC_TEST', 'description': 'different samples were collected from patients admitted at oncology center at sohag', 'armGroupLabels': ['Group 1 Patients with enterobacterials infections', 'Group 2 patients with other bacterial infections']}, {'name': 'Molecular detection of antibiotic resistance', 'type': 'DIAGNOSTIC_TEST', 'description': 'Molecular detection of carbapenem resistant genes:\n\n* Extraction of nucleic acid from isolated organisms by boiling.\n* Primers will be used for detection of carbaenem resistant genes', 'armGroupLabels': ['Group 1 Patients with enterobacterials infections', 'Group 2 patients with other bacterial infections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '534568', 'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'sohag University, professor', 'role': 'CONTACT', 'email': 'Sohaguniversity@med.sohag.edu.eg', 'phone': '+201063452930'}], 'facility': 'Sohag university, Faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Noha Saber Shafik, Assistant professor', 'role': 'CONTACT', 'email': 'nohasaber@med.sohag.edu.eg', 'phone': '+201067261504'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Noha Saber Shafik', 'investigatorAffiliation': 'Sohag University'}}}}