[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440628":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":39,"centralContacts":44,"locations":51,"responsibleParty":93,"collaborators":95,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":10,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"A) Urinary tract infection",null,"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\u002Fmass 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.",[13],"Other: analysis of antimicrobial resistance",{"label":15,"type":10,"description":16,"interventionNames":17},"B) Pneumonia","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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"C) Deep-seated infections","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.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"D) Controls for A), B) and C)","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",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"E) Clinical controls for A), B) and C) without obtained samples","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.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"F) Cohort with analysis whether the application of Article (Art) 34 HFV can avoid a bias","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.",[13],[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"analysis of antimicrobial resistance","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\u002Fmortality) and treatment response (response or failure) will be correlated to the in vitro retrieved host and bacterial data.",[9,15,19,23,27,31],[40],{"name":41,"affiliation":42,"role":43},"Nina Khanna, Prof.","University Hospital Basel, Division of Infectiology","PRINCIPAL_INVESTIGATOR",[45,49],{"name":41,"role":46,"phone":47,"phoneExt":10,"email":48},"CONTACT","+41 61 328 73 25","nina.khanna@usb.ch",{"name":50,"role":46,"phone":10,"phoneExt":10,"email":10},"Christoph Dehio, Prof.",[52],{"facility":53,"status":54,"city":55,"state":10,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"University Hospital Basel","RECRUITING","Basel","4031","Switzerland","CH",{"type":60,"coordinates":61},"Point",[62,63],7.57327,47.55839,{"lat":63,"lon":62},[66,68,72,73,76,78,79,81,83,85,87,89,91],{"name":67,"role":46,"phone":47,"phoneExt":10,"email":48},"Nina Khanna, Prof. Dr. med.",{"name":69,"role":46,"phone":70,"phoneExt":10,"email":71},"Richard Kühl, Dr. med.","+41 61 328 65 45","richard.kuehl@usb.ch",{"name":41,"role":43,"phone":10,"phoneExt":10,"email":10},{"name":74,"role":75,"phone":10,"phoneExt":10,"email":10},"Richard Kühl, Dr.","SUB_INVESTIGATOR",{"name":77,"role":75,"phone":10,"phoneExt":10,"email":10},"Adrian Egli, Prof.",{"name":50,"role":75,"phone":10,"phoneExt":10,"email":10},{"name":80,"role":75,"phone":10,"phoneExt":10,"email":10},"Mario Morgenstern, PD",{"name":82,"role":75,"phone":10,"phoneExt":10,"email":10},"Martin Siegemund, Prof.",{"name":84,"role":75,"phone":10,"phoneExt":10,"email":10},"Daiana Stolz, Prof.",{"name":86,"role":75,"phone":10,"phoneExt":10,"email":10},"Sarah Tschudin Sutter, Prof.",{"name":88,"role":75,"phone":10,"phoneExt":10,"email":10},"Bram Stieltjes, Dr.",{"name":90,"role":75,"phone":10,"phoneExt":10,"email":10},"Dirk Buman, Prof.",{"name":92,"role":75,"phone":10,"phoneExt":10,"email":10},"Urs Jenal, Prof.",{"type":94,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[96],{"name":97,"class":6},"Swiss National Science Foundation","100440628","nccr-antiresist-new-approaches-to-combat-antibiotic-resistant-bacteria-100440628",false,"NCT05017766","NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria","NCCR AntiResist: Mono-center Study to Identify New Approaches to Combat Antibiotic-resistant Bacteria.","AntiResist","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\u002Fsamples (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: \\\u003C18 years\n* Controls without signed general consent",true,"ALL","18 Years",{"count":110,"type":111},8000,"ESTIMATED","OBSERVATIONAL","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.",[115],"Antimicrobial Resistance (AMR)",[117,118,119,120,121,122,123,124,125,126,127,128,129],"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)","2025-02-27",{"date":132,"type":133},"2025-03-04","ACTUAL",{"date":135,"type":133},"2020-12-03",{"date":137,"type":111},"2028-12",{"name":5,"class":6},1]