[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"skin-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:skin-infection":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,65,97,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878",false,"NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"ALL","0 Years","20 Years",{"count":22,"type":23},5000,"ESTIMATED","OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","RECRUITING","2026-03-31",{"date":55,"type":56},"2026-04-06","ACTUAL",{"date":58,"type":56},"2020-03-05",{"date":60,"type":23},"2027-07",{"name":62,"class":63},"Duke University","OTHER",51,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100508340","phase-4-adjunctive-clindamycin-for-the-treatment-of-skin-and-soft-tissue-infections-a-randomized-controlled-trial-100508340","NCT05899140","Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial","Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial","SoTiClin","Inclusion Criteria:\n\n1. Adults (age ≥18 years);\n2. Need for a treatment (incision\u002Fdrainage ± antibiotic treatment po or iv) of an SSTI;\n3. S. aureus causing SSTI identified from at least one clinical specimen (including isolation in polymicrobial cultures if S. aureus is considered to be the leading pathogen);\n4. Onset of symptoms within the last 4 weeks;\n5. Randomisation possible within 72 hours from collection of the initial culture\n6. Ability to conduct the follow-up visits either during admission or at home\n7. Initial culture collected within 48 hours of hospital admission\n8. Willingness to participate in the study.\n\nExclusion Criteria\n\n1. Previous allergic reaction to clindamycin\n2. Previous antibiotic-associated diarrhea\n3. Previous study participation\n4. Pregnancy as confirmed by a beta-HCG rapid test.\n5. Started treatment with clindamycin prior to clinic presentation;\n6. Documented systemic antibiotic treatment within the previous 14 days\n7. Co-administration of other protein synthesis inhibitors (e.g. macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol);\n8. Co-administration of toxin inducers (trimethoprim-sulfamethoxazole)\n9. Severe illness (patient expected to die in the following 24 hrs);\n10. Chronically infected wounds (\\>4 weeks of symptoms);\n11. Infections associated with any of the following (due to mixed infection): a) Human or animal bites;b) Prosthetic or implantable devices; c) Decubitus ulcers; d) Diabetic foot ulcers, infected ulcers secondary to peripheral artery disease, chronic venous insufficiency; e) Suspected Buruli ulcer; f) Infected burns.\n12. Hospital-acquired infection including post-surgical site infections","18 Years",{"count":75,"type":23},100,"INTERVENTIONAL",[78],"PHASE4","This is an exploratory study to evaluate the effect of adjunctive clindamycin in the treatment of skin and soft-tissue infections due to Staphylococcus aureus in patients from Sierra Leone. The study hypothesizes that clindamycin, when added to routine treatment, will lead to a more rapid clinical resolution and less frequent recurrences of infection.",[41,81,82],"Staphylococcal Infections","Staphylococcus Aureus Infection",[84,85,86],"SSTI","Staphylococcus aureus","Panton-Valentine leukocidin","2024-12-04",{"date":89,"type":56},"2024-12-09",{"date":91,"type":56},"2024-03-15",{"date":93,"type":23},"2026-07-31",{"name":95,"class":63},"Frieder Schaumburg",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":105,"targetDuration":107,"studyType":24,"phases":4,"briefSummary":108,"conditions":109,"keywords":127,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":96},"100409713","acutelines-a-large-data-biobank-of-acute-and-emergency-medicine-100409713","NCT04615065","Acutelines: a Large Data-\u002FBiobank of Acute and Emergency Medicine","Acutelines: a Large Biobank Aiming to Improve Early Recognition of Acute Diseases, Contribute to the Development of Personalized Medicine and Optimize Short- and Long-term Outcome","Acutelines","Inclusion Criteria, at least one of the following:\n\n* Triaged as one of highest two triage categories (red or orange) according to the Manchester triage system;\n* Triaged as the third highest triage category (yellow) and arrival by EMS of Helicopter Emergency Medical Service (HEMS;\n* Shock\n* Suspicion of sepsis (based on either physicians' suspicion, Sepsis-2 or Sepsis-3 criteria)\n* Acute kidney injury (AKI)\n* Anaphylactic reaction\n* Syncope\n* Intoxication\n* Thrombosis\n* Pulmonary embolism\n* Bleeding while using anti-coagulant drugs\n* Gastro-intestinal bleeding\n* Electrolyte disturbance\n\nExclusion Criteria:\n\n* Referred for organ transplantation as recipient\n* Transfer from other hospital\n* Accidental contact patient material (i.e. internal work-related accident)\n\nWhile data- and imaging will be collected from all these patients, biomaterials will only be collected from patients fulfilling the first criterion (i.e. triaged as one of highest two triage categories \\[red or orange\\] according to the Manchester triage system) and from patients with shock or a suspicion of sepsis.",{"count":106,"type":23},35000,"5 Years","Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named \"Acutelines\". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment and improves prediction of patient outcomes after an acute admission.",[110,111,40,112,113,114,115,116,117,118,119,120,121,122,123,41,124,125,126],"Acute Disease","Sepsis","Frailty","Complication of Treatment","Pulmonary Embolism","Thrombosis","Acute Kidney Injury","Electrolyte Disturbance","Hemorrhage","Shock","Polypharmacy","Intoxication by Drug","Emergencies","Urinary Tract Infections","Syncope","Anaphylaxis","Dyspnea",[128,111,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149],"Acute disease","Emergency Medical Service (EMS)","Outcome","Precision medicine","Personalized medicine","Emergency medicine","Multidisciplinary","General practitionar","Pharmacy","Hospitalization","Health insurance","Mortality","Quality of life (QoL)","Overcrowding","Patient logistics","Point-of-care ultrasound (POCUS)","Helicopter Emergency Medical Service (HEMS)","Biobank","Databank","Electrophysiological waveforms","Electrocardiogram (ECG)","Plethysmogram","2024-06-12",{"date":152,"type":56},"2024-06-13",{"date":154,"type":56},"2020-09-01",{"date":156,"type":23},"2030-09-01",{"name":158,"class":63},"University Medical Center Groningen",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":17,"sex":18,"minAge":73,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":76,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":4},"100529223","skin-inflammation-and-pk-of-azithromycin-100529223","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","55 Years",{"count":169,"type":23},36,[171],"NA","This study will investigate the tissue distribution of azithromycin in healthy, artificially inflamed and actually infected tissue of humans.",[41],"NOT_YET_RECRUITING","2023-12-13",{"date":177,"type":56},"2023-12-14",{"date":179,"type":23},"2024-01-01",{"date":181,"type":23},"2026-07-01",{"name":183,"class":63},"Medical University of Vienna"]