[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529223":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":40,"collaborators":30,"id":44,"slug":30,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":30,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":30,"overallStatus":64,"whyStopped":30,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":30},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Pilot Cohort for Skin Inflammation","EXPERIMENTAL","Testing skin inflammation",[13,14],"Diagnostic Test: Biopsy","Other: Skin inflammation model",{"label":16,"type":10,"description":17,"interventionNames":18},"Azithromycin and Artificial Skin Inflammation","Investigating tissue PK of Azithromycin in artificially inflamed tissue",[19,14],"Drug: Azithromycin",{"label":21,"type":10,"description":22,"interventionNames":23},"Azithromycin and Skin Infection","Investigating tissue PK of Azithromycin in actually infected tissue",[19],[25,31,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Azithromycin","500 mg once daily for 3 days",[16,21],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DIAGNOSTIC_TEST","Biopsy","Skin punch biopsy",[9],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Skin inflammation model","LPS- or imiquimod induced skin inflammation",[16,9],{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Markus Zeitlinger","MD","100529223",false,"NCT06170983","Skin Inflammation and PK of Azithromycin","Validation of Imiquimod- and LPS-induced Skin Inflammation Models and Their Application in the Investigation of Azithromycin Concentration in Inflamed, Infected, and Healthy Subcutaneous Tissue","AZI_IMQ_LPS","Inclusion Criteria:\n\n* • Men and women aged ≥18 and \\\u003C55 years\n\n  * BMI ≥18 and ≤30 kg\u002Fm2\n  * Normal (or clinically irrelevant abnormal) findings in medical history and physical examination\n  * Women with child-bearing potential: use of effective contraception\n  * Laboratory parameters within the given reference range (or abnormal findings which are irrelevant for study purposes in the Investigator's opinion)\n\nExclusion Criteria:\n\n* Known or suspected allergy to lipopolysaccharide, imiquimod, or sticking plasters\n* Only Part 0c: Known or suspected allergy to local anesthetics\n* History of severe allergic or anaphylactic reactions to any medication • Blood donation within the last 4 weeks before the study\n* Treatment with an investigational drug within three weeks before the study\n* Smoking of more than 5 cigarettes per day\n* Regular use of medication or abuse of alcohol\n* Use of any medication within one week before the study\n* Symptoms of a clinically relevant illness in the 3 months before the study\n* Liver or kidney dysfunction\n* Pregnancy\n* History of autoimmune diseases (especially psoriasis)\n* Other objections to participating in the study in the opinion of the Investigator",true,"ALL","18 Years","55 Years",{"count":56,"type":57},36,"ESTIMATED","INTERVENTIONAL",[60],"NA","This study will investigate the tissue distribution of azithromycin in healthy, artificially inflamed and actually infected tissue of humans.",[63],"Skin Infection","NOT_YET_RECRUITING","2023-12-13",{"date":67,"type":68},"2023-12-14","ACTUAL",{"date":70,"type":57},"2024-01-01",{"date":72,"type":57},"2026-07-01",{"name":5,"class":6}]