[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508340":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Universität Münster","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Standard of care","Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous). Treatment according to local guidelines = standard of care: usually an anti-staphylococcal penicillin with or without incision and drainage, as required.\n\nTreatment can be with (local guidelines) cloxacillin (non-severe) po 500g QIDfor 5-7 days ceftriaxone (severe infections) 2g iv OD with step-down to cloxacillin po 500 mg QID for a total of 7 days",[12],"Other: Standard of care",{"label":14,"type":15,"description":16,"interventionNames":17},"Standard of care + clindamycin","ACTIVE_COMPARATOR","Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous).\n\nAddition of clindamycin: 10 mg\u002Fkg\u002Fdose QID iv (maximum 600mg QID iv) or oral clindamycin 450 mg TDS for adults for a total of 7 days from randomisation.",[18,12],"Drug: Clindamycin",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Clindamycin","Clindamycin will be administered at a dose of 450 mg TDS (oral) or 10 mg\u002Fkg\u002Fdose QID iv (maximum 600mg QID iv) for a maximum of 7 days",[14],null,{"type":6,"name":9,"description":9,"armGroupLabels":27,"otherNames":25},[9,14],[29],{"name":30,"affiliation":5,"role":31},"Frieder Schaumburg, MD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":25,"email":36},"CONTACT","+492518352767","frieder.schaumburg@ukmuenster.de",{"name":38,"role":34,"phone":25,"phoneExt":25,"email":39},"Ioana D Olaru, PhD","ioanadiana.olaru@ukmuenster.de",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Masanga Hospital","RECRUITING","Masokori","Sierra Leone","SL",{"type":48,"coordinates":49},"Point",[50,51],-11.82603,8.78768,{"lat":51,"lon":50},[54],{"name":55,"role":34,"phone":25,"phoneExt":25,"email":25},"Emmanuel M Kanu, MB BS",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Frieder Schaumburg","Principal Investigator, Professor","100508340","phase-4-adjunctive-clindamycin-for-the-treatment-of-skin-and-soft-tissue-infections-a-randomized-controlled-trial-100508340",false,"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","ALL","18 Years",{"count":71,"type":72},100,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78,79,80],"Skin Infection","Staphylococcal Infections","Staphylococcus Aureus Infection",[82,83,84],"SSTI","Staphylococcus aureus","Panton-Valentine leukocidin","2024-12-04",{"date":87,"type":88},"2024-12-09","ACTUAL",{"date":90,"type":88},"2024-03-15",{"date":92,"type":72},"2026-07-31",{"name":58,"class":6},1]