[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416261":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":30,"locations":36,"responsibleParty":58,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":10,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University Hospital of Cologne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Cystic Fibrosis",null,"Patients with pulmonary Cystic Fibrosis with or without bacterial colonization",[13],"Other: Blood sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"Control group","Healthy age- and sex-matched controls including healthy individuals and patients with acute or chronic bacterial infections",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Blood sampling","Screening: Blood sampling of 15 ml whole blood\n\nB cell isolation: Blood sampling of max. 400 ml whole blood or 6% of the total blood volume (♀ 65 ∓ 10 ml\u002Fkg; ♂ 77 ∓ 10 ml\u002Fkg)",[15,9],[24,28],{"name":25,"affiliation":26,"role":27},"Silke van Koningsbruggen-Rietschel, MD, PhD","University Hospital Cologne","STUDY_DIRECTOR",{"name":29,"affiliation":26,"role":27},"Jan Rybniker, MD, PhD",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Alexander Simonis","CONTACT","+4922147889608","alexander.simonis@uk-koeln.de",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"CF Study Center, University Hospital Cologne","RECRUITING","Cologne","Germany","DE",{"type":44,"coordinates":45},"Point",[46,47],6.95,50.93333,{"lat":47,"lon":46},[50,51,53,55,56],{"name":25,"role":33,"phone":10,"phoneExt":10,"email":10},{"name":25,"role":52,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":54,"role":52,"phone":10,"phoneExt":10,"email":10},"Ernst Rietschel, MD",{"name":29,"role":52,"phone":10,"phoneExt":10,"email":10},{"name":57,"role":52,"phone":10,"phoneExt":10,"email":10},"Alexander Simonis, MD",{"type":52,"investigatorFullName":32,"investigatorTitle":59,"investigatorAffiliation":60,"oldNameTitle":10,"oldOrganization":10},"MD","University of Cologne","100416261","characterization-of-antibacterial-antibodies-in-patients-with-cystic-fibrosis-100416261",false,"NCT04700358","Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis","Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to give consent\n* Normal vital signs including:\n* Blood pressure systolic value 150 - 100 mmHg, diastolic value \\\u003C 90 mmHg\n* Respiratory rate \\\u003C 20\u002Fmin\n* Oxygen saturation \\>92%\n* Heart rate 50 - 110\u002Fmin\n* Body temperature \\\u003C38°C\n\nExclusion Criteria:\n\n* Cytopenia (leukocytes \\\u003C 1.500\u002Fµl, thrombocytes \\\u003C 50.000\u002Fµl, Hemoglobin \\\u003C 12 g\u002Fdl)\n* Heart disease or pulmonary hypertension\n* Body weight \\\u003C50 kg (exclusion of blood sampling for B cell isolation)\n* Blood donation, larger blood loss and\u002For major surgery in the last 8 (male) or 12 (female) weeks\n* Any decline of the general state of health in the last 3 month including weight loss \\> 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 \\\u003C 50%)",true,"ALL","18 Years",{"count":72,"type":73},75,"ESTIMATED","OBSERVATIONAL","Most of the cystic fibrosis (CF) patients are or have been pulmonary colonized with bacteria such as Pseudomonas aeruginosa or Staphylococcus aureus. Aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by B cell repertoire analyses to design B cell-derived neutralizing monoclonal antibodies. The functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. Focusing on patients with bacterial colonization\u002Fchronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. Since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.",[77,78],"Pulmonary Cystic Fibrosis","Neutralizing Antibodies","2024-05-07",{"date":81,"type":82},"2024-05-08","ACTUAL",{"date":84,"type":82},"2020-10-01",{"date":86,"type":73},"2027-12-31",{"name":5,"class":6},1]