Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:01 PM
Study NCT ID:
NCT07369518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-17', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1 ISOLATION OF KLEB. by culture on macConkey agar', 'timeFrame': '6 months from January to may'}, {'measure': 'Antibiotic sensitivity testing of different antibiotics according to clsi 25', 'timeFrame': '6 months from January to may'}, {'measure': 'Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae', 'timeFrame': '6 months from January to may'}, {'measure': 'Detection of resistance gene in isolates using conventional pcr', 'timeFrame': '6 months from June to December'}, {'measure': 'Detection of some virulence genes using conventional pcr', 'timeFrame': '6 months from June to December'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ISOLATION OF KLEB. by Culture on macConkey Agar', 'Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25', 'Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae', 'Detection of Resistance Gene in Isolates Using Conventional Pcr', 'Detection of Some Virulence Genes Using Conventional Pcr']}, 'descriptionModule': {'briefSummary': 'Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.\n\nBacterial identification by Gram stain, culture and biochemical rections\n\n* analysisThe resistance pattern of the isolates will be detected by disc diffusion method.\n* phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.', 'detailedDescription': 'Carbapenem-resistant Enterobacterales (CRE) poses an urgent global public health threat, with more than 1,100 documented deaths, as reported in a 2019 antibiotic resistance publication by the U.S. Centers for Disease Control and Prevention.\n\nCarbapenem-resistant Enterobacterales, including carbapenem-resistant Klebsiella pneumoniae (CRKP), is associated with higher mortality compared with infections caused by carbapenem-susceptible Enterobacterales infections Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups.\n\nBacterial identification by Gram stain, culture and biochemical rections\n\n* analysisThe resistance pattern of the isolates will be detected by disc diffusion method.\n* phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All selected patients subjected to complete history All samples transported to medical microbiology department', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections.-\n\nExclusion Criteria:\n\n* Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production.'}, 'identificationModule': {'nctId': 'NCT07369518', 'briefTitle': 'Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Effect of Ceftazidime-Avibactam Against Carbapenemase-Positive Klebsiella Pneumoniae Causing Health Care-Associated Infections', 'orgStudyIdInfo': {'id': 'Soh-Med-25-12-2MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 patients with klebsiella pneumoniae infection', 'description': 'Infections caused by klebsiella pneumoniae like skin infections, chest infections, surgical site infections, and urinary tract Infections.', 'interventionNames': ['Genetic: . - Genotypic detection of carbapenemase genes by conventional PCR.']}, {'label': 'Group 2 patients without klebsiella pneumoniae', 'description': 'Infections caused by any organisms other than klebsiella pneumoniae and carbapenem resistant klebsiella pneumoniae by mechanism other than carbapenemases production.', 'interventionNames': ['Genetic: . - Genotypic detection of carbapenemase genes by conventional PCR.']}], 'interventions': [{'name': '. - Genotypic detection of carbapenemase genes by conventional PCR.', 'type': 'GENETIC', 'description': 'Specimen Collection : Clinical specimens included blood, urine, bronchoalveolar lavage fluid, wound, peritoneal fluid, and tracheal aspirate obtained from patients with suspected bacterial infections collected in dry sterile well-closed plastic cups. Bacterial identification by Gram stain, culture and biochemical rections - analysisThe resistance pattern of the isolates will be detected by disc diffusion method. - phenotypic detection of carbapenemases. • Detection of carbapenem resistance genes (KPC, VIM, IMP, OXA-48, NDM) by conventional PCR.', 'armGroupLabels': ['Group 1 patients with klebsiella pneumoniae infection', 'Group 2 patients without klebsiella pneumoniae']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of medicine Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Walaa Ismael, Demonstrator', 'role': 'CONTACT', 'email': 'walaa.marzouk@med.sohag.edu.eg', 'phone': '+20114 8736091'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator at medical microbiology and immunology department faculty of medicine so', 'investigatorFullName': 'Walaa ismail Marzouk', 'investigatorAffiliation': 'Sohag University'}}}}