Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-04-16 @ 12:41 AM
Study NCT ID:
NCT05017766
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D004927', 'term': 'Escherichia coli Infections'}, {'id': 'D007710', 'term': 'Klebsiella Infections'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}], '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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Residual samples from routinely collected material (urine, tracheal secretion in intubated patients, sputum in cystic fibrosis patients, bronchoalveolar lavage fluid, blood, deep-seated infectious material that is surgically removed).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome: survival rate', 'timeFrame': 'one time assessment at baseline', 'description': 'Survival rate (correlated to the in vitro retrieved host and bacterial data. In vitro retrieved host and bacterial data include: Proteomics, Metabolomics, FISH, Histology, PCR/Microbial genome sequencing, Microbial transcriptome, Antibiotic concentration, Timelapse studies, phenotypic characterisations, molecular typing, innate immune response characterization, Antibiotic tolerance testing, Microfluidic systems, 3-D models, Transcriptomics, Flow cytometry (FACS))'}, {'measure': 'Clinical outcome: mortality rate', 'timeFrame': 'one time assessment at baseline', 'description': 'Mortality rate (correlated to the in vitro retrieved host and bacterial data. In vitro retrieved host and bacterial data include: Proteomics, Metabolomics, FISH, Histology, PCR/Microbial genome sequencing, Microbial transcriptome, Antibiotic concentration, Timelapse studies, phenotypic characterisations, molecular typing, innate immune response characterization, Antibiotic tolerance testing, Microfluidic systems, 3-D models, Transcriptomics, Flow cytometry (FACS))'}, {'measure': 'Treatment response (binary: yes/ no)', 'timeFrame': 'one time assessment at baseline', 'description': 'Treatment response (correlated to the in vitro retrieved host and bacterial data. In vitro retrieved host and bacterial data include: Proteomics, Metabolomics, FISH, Histology, PCR/Microbial genome sequencing, Microbial transcriptome, Antibiotic concentration, Timelapse studies, phenotypic characterisations, molecular typing, innate immune response characterization, Antibiotic tolerance testing, Microfluidic systems, 3-D models, Transcriptomics, Flow cytometry (FACS))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['National Center of Competence in Research (NCCR)', 'Urinary tract infection (UTI)', 'Pneumonia', 'Deep-seated infections', 'E. coli', 'Klebsiella species', 'S. aureus', 'P. aeruginosa', 'bacterial properties', 'Community-acquired pneumonia (CAP)', 'Hospital-acquired pneumonia (HAP)', 'Ventilator-associated pneumonia (VAP)', 'cystic fibrosis (CF)'], 'conditions': ['Antimicrobial Resistance (AMR)']}, 'descriptionModule': {'briefSummary': 'This is an explorative, mono-center study including prospectively collected patient samples from the University Hospital of Basel. It is to investigate antimicrobial resistance (AMR) including three clinical manifestations of infectious diseases: urinary tract infection, pneumonia and deep-seated infections. The focus is on four bacteria (E. coli, Klebsiella species, S. aureus, P. aeruginosa) that are part of the high priority list of World Health Organization (WHO). Residual patient samples are analysed for proteomic, metabolomic and transcriptomic analysis, immunocytochemical or fluorescence in-situ hybridisation (FISH) analysis, flow cytometry analysis (FACS) and immunophenotyping and exploration of bacterial properties.', 'detailedDescription': 'The National Center of Competence in Research (NCCR) AntiResist aims at utilizing patient samples in order to investigate the physiology of bacterial pathogens in human patients and establishing a unique multidisciplinary network of clinicians, biologists, engineers, chemists, computational scientists and drug developers.\n\nThe goal of this project is to elucidate the physiological properties of bacterial pathogens in infected human patients in order to provide new ways of combatting superbugs. These clinical data will be used to guide and benchmark development of patient-mimicking and in-vitro models, accelerate the search for novel bacterial targets, antibacterial compounds and non-conventional strategies.\n\nIn detail, the focus will be on three clinical manifestations of infectious diseases caused by four critical bacterial pathogens belonging to WHO "priority pathogens" list: E. coli, Klebsiella species, S. aureus and P. aeruginosa :\n\nA) Urinary tract infection B) Pneumonia C) Deep-seated infections D) Controls for A), B) and C) E) Clinical controls for A), B) and C) without obtained samples F) Analysis whether the application of Art. 34 HFV (Weiterverwendung biologischen Materials und/oder gesundheitsbezogener Personendaten für die Forschung bei fehlender Einwilligung und Information) can avoid a bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient samples during routine collection at the University Hospital of Basel from November 2020 to approximately December 2024.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with confirmed (i) urinary tract infection, (ii) pneumonia (including patients after lung transplantation, cystic fibrosis) or (iii) deep-seated infection with focus pathogen:\n\n * E. coli\n * Klebsiella species\n * S. aureus\n * P. aeruginosa\n* Controls: no detectable bacteria in routine microbiology lab and no other infection site at inclusion of the sample and follow up for 10 days, signed general consent\n* Clinical controls without obtained samples, but with confirmed (i) urinary tract infection, (ii) pneumonia (including patients after lung transplantation, cystic fibrosis) or (iii) deep-seated infection with focus pathogen:\n\n * E. coli\n * Klebsiella species\n * S. aureus\n * P. aeruginosa\n\nExclusion Criteria:\n\n* Patients who have refused research and reuse of their data/samples (e.g. general consent) or any other decline (e.g. Patientenverfügung).\n* other than one of the focus bacteria in routine microbiology lab\n* Age: \\<18 years\n* Controls without signed general consent'}, 'identificationModule': {'nctId': 'NCT05017766', 'acronym': 'AntiResist', 'briefTitle': 'NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'NCCR AntiResist: Mono-center Study to Identify New Approaches to Combat Antibiotic-resistant Bacteria.', 'orgStudyIdInfo': {'id': '2020-02588; pe20Khanna'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A) Urinary tract infection', 'description': 'Processing of residual urine for proteomic, metabolomic and transcriptomic analysis, immunocytochemical or fluorescence in-situ hybridisation (FISH) analysis, flow cytometry analysis (FACS), immunophenotyping. If positive for target bacteria: sample stored at biobank. If previous antibiotic treatment: plasma sample storage. Exploration of bacterial properties (Highly sensitive mass spectrometry, whole genome sequencing), expression of virulence factors, genomic alterations of bacterial species, metabolism, surface molecule expression, gene expression levels, cytokine levels, immune cell biology, antibiotic concentration (chromatography/mass spectrometry). Demographical, clinical, microbiological, laboratory, epidemiological and hospital-associated data will be analysed. 500 samples per target bacteria (S. aureus, P. aeruginosa, E. coli, Klebsiella species) included. First, a pilot study from randomly selected patients within each bacterial species group (n=50, each) is done.', 'interventionNames': ['Other: analysis of antimicrobial resistance']}, {'label': 'B) Pneumonia', 'description': 'Processing of residual samples (tracheal secretion, bronchioalveolar lavage (BAL)) for proteomic, metabolomic, transcriptomic and cytological analysis. If positive for target bacteria: sample stored at biobank. If previous antibiotic treatment: plasma sample storage. Exploration of bacterial properties. Demographical, clinical, microbiological, laboratory, epidemiological and hospital-associated data will be analysed. 500 samples per target bacteria (S. aureus, P. aeruginosa, E. coli, Klebsiella species) included.', 'interventionNames': ['Other: analysis of antimicrobial resistance']}, {'label': 'C) Deep-seated infections', 'description': 'Processing of intraoperative material residual samples for proteomic, metabolomic, transcriptomic and cytological analysis. If positive for target bacteria: sample stored at biobank. Exploration of bacterial properties. Demographical, clinical, microbiological, laboratory, epidemiological and hospital-associated data will be analysed. 500 samples per target bacteria (S. aureus, P. aeruginosa, E. coli, Klebsiella species) included.', 'interventionNames': ['Other: analysis of antimicrobial resistance']}, {'label': 'D) Controls for A), B) and C)', 'description': 'Control samples result from patients with a suspected infection (infection sites A), B) or C), in which no microbiological confirmed infection has been diagnosed. Storage at biobank', 'interventionNames': ['Other: analysis of antimicrobial resistance']}, {'label': 'E) Clinical controls for A), B) and C) without obtained samples', 'description': 'For clinical controls, clinical characteristics of patients with detection of target pathogens in their routine samples (but which could not be included for sample analysis in this study) will be assessed.', 'interventionNames': ['Other: analysis of antimicrobial resistance']}, {'label': 'F) Cohort with analysis whether the application of Article (Art) 34 HFV can avoid a bias', 'description': 'Since part of the data and samples in this study are collected with the representative consent of the ethics committees, it is investigated whether the application of Art. 34 HFV prevents selection bias with respect to the study population. For this purpose, differences between the actual study population using Art. 34 HFV and the study population with provided research consent will be descriptively investigated in terms of the prevalence of multi-resistant germs and other available population characteristics.', 'interventionNames': ['Other: analysis of antimicrobial resistance']}], 'interventions': [{'name': 'analysis of antimicrobial resistance', 'type': 'OTHER', 'description': 'In samples from patients infected with one of the focus pathogens (E. coli, Klebsiella species, S. aureus, P. aeruginosa) will be:\n\n(i) isolated and pathogenic bacteria characterized; (ii) pathogen in-situ properties at single-cell and bulk average determined; (iii) human metabolites, proteins and cells determined (iv) antibiotic concentration determined (v) bacterial growth monitored\n\nDeducted from the data will be:\n\n1. relevant human components and pathogen properties that are common to most patients with similar indication\n2. underlying regulatory networks and triggers in pathogen cells and human tissues.\n\nClinical outcomes (survival/mortality) and treatment response (response or failure) will be correlated to the in vitro retrieved host and bacterial data.', 'armGroupLabels': ['A) Urinary tract infection', 'B) Pneumonia', 'C) Deep-seated infections', 'D) Controls for A), B) and C)', 'E) Clinical controls for A), B) and C) without obtained samples', 'F) Cohort with analysis whether the application of Article (Art) 34 HFV can avoid a bias']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nina Khanna, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'nina.khanna@usb.ch', 'phone': '+41 61 328 73 25'}, {'name': 'Richard Kühl, Dr. med.', 'role': 'CONTACT', 'email': 'richard.kuehl@usb.ch', 'phone': '+41 61 328 65 45'}, {'name': 'Nina Khanna, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Richard Kühl, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adrian Egli, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christoph Dehio, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mario Morgenstern, PD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martin Siegemund, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daiana Stolz, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah Tschudin Sutter, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bram Stieltjes, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dirk Buman, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Urs Jenal, Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Nina Khanna, Prof.', 'role': 'CONTACT', 'email': 'nina.khanna@usb.ch', 'phone': '+41 61 328 73 25'}, {'name': 'Christoph Dehio, Prof.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Nina Khanna, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Division of Infectiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}