[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Infectopharm Arzneimittel GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":41,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100284234","fosfomycin-iv-for-treatment-of-severely-infected-patients-100284234",false,"NCT02979951","Fosfomycin I.v. for Treatment of Severely Infected Patients","An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.","FORTRESS","Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.\n* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC\n* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)\n\nExclusion Criteria:\n\n* Previous documentation of the patient in the present study\n* Patients participating in an interventional clinical trial\n* Patients with known hypersensitivity to fosfomycin or any of the excipients\n* Terminally ill patients\n* Patients with \"do not resuscitate order\"\n* Palliative treatment approach\n* Failure of \\> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney\n* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)\n* Fosfomycin treatment as 4th line treatment or at later stage\n* Patients with involvement of fungi or mycobacteria in the targeted infection","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Bacterial Infections","Bone Diseases, Infectious","Osteomyelitis","Central Nervous System Bacterial Infections","Meningitis, Bacterial","Encephalitis","Brain Abscess","Urinary Tract Infections","Respiratory Tract Infections","Pneumonia, Bacterial","Skin Diseases, Bacterial","Soft Tissue Infections","Intraabdominal Infections","Sepsis","Bacteremia","Endocarditis, Bacterial",[42,43,44,45,46,47,48,49,50,51,25,52,53,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,54,55,56,57],"Observational Study","Non-Interventional Study","Registries","Prospective","Monitored","Multicentric","International","Fosfomycin","Infectofos","Fomicyt","Gram-Negative Bacterial Infections","Gram-Positive Bacterial Infections","Treatment Outcome","Clinical Efficacy","Microbiological Efficacy","Safety","RECRUITING","2024-09-27",{"date":61,"type":62},"2024-10-01","ACTUAL",{"date":64,"type":4},"2016-12",{"date":66,"type":21},"2030-12",{"name":68,"class":69},"Infectopharm Arzneimittel GmbH","INDUSTRY",50,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100545326","phase-3-therapy-for-scabies-with-two-differently-concentrated-permethrin-creams-100545326","NCT06380452","Therapy for Scabies With Two Differently Concentrated Permethrin Creams","Phase III Multicenter, Prospective, Randomized, Double-blind Study Comparing the Efficacy and Safety of Therapy for Scabies With Two Differently Concentrated Permethrin Creams.","SKABUP","Inclusion Criteria:\n\n* Confirmed acute scabies disease: Detection of mites and\u002For mite nymphs and\u002For mite larvae, by reflected light microscopy or light microscopy of skin samples, at scabies-typical predilection sites\n* Age between 2 years and 85 years\n* Written informed consent of the study participant (if of legal age) or all legal guardians (for underage study participants \\\u003C 12 years) or all legal guardians and the study participant (for underage study participants ≥ 12 years)\n* Practicable application of the trial medication by trained specialist staff at the trial site\n\nExclusion Criteria:\n\n* Pre-treatment with antiscabiosa in the last 14 days\n* Combined antiscabial treatment (i.e. simultaneous\u002Fsimultaneous topical and systemic scabies treatment with medication) in the last 3 months\n* Known intolerance to permethrin, other pyrethroids, chrysanthemums or any of the other ingredients of the study medication\n* Scabies crustosa\n* Impetiginization\u002Feczematization requiring inpatient treatment\n* Body weight \\> 120 kg\n* Pregnancy, breastfeeding\n* Clinically relevant immunodeficiency (of any kind, including extensive local therapy (\\>20% body surface) with corticosteroids \\> 2 weeks in the last 4 weeks or ≥ 10 mg prednisolone equivalent \\>7 days in the last 4 weeks - even without signs of scabies crustosa)\n* Other serious illnesses which, in the opinion of the investigator, prevent the patient from participating in the study\n* Planned systemic use of corticosteroids\n* Planned or previous (last 4 weeks) use of systemic or cutaneous non-steroidal immunosuppressants\n* Apparent unreliability or unwillingness to cooperate\n* Inability to understand and comply with study instructions\n* Known alcohol, medication or drug dependence\n* Placement in a facility where people live together for long periods of time, are cared for or receive medical care, and where close skin-to-skin contact is common, or placement in an institution ordered by a court\u002Fauthority\n* 5 or more close contacts (persons with close, extensive skin-to-skin contact with the scabies patient for more than 5-10 minutes)\n* Close contact person who refuses scabies treatment or for whom treatment is not possible\n* Dependence on sponsor or investigator\n* Previous participation in a clinical trial in the last 30 days or in the same clinical trial","2 Years","85 Years",{"count":82,"type":21},220,"INTERVENTIONAL",[85],"PHASE3","The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.\n\nThe trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%.",[88],"Scabies","NOT_YET_RECRUITING","2024-04-22",{"date":92,"type":62},"2024-04-23",{"date":94,"type":21},"2024-05",{"date":96,"type":21},"2028-12",{"name":68,"class":69},""]