[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Frieder Schaumburg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Skin Infection","Staphylococcal Infections","Staphylococcus Aureus Infection",[31,32,33],"SSTI","Staphylococcus aureus","Panton-Valentine leukocidin","RECRUITING","2024-12-04",{"date":37,"type":38},"2024-12-09","ACTUAL",{"date":40,"type":38},"2024-03-15",{"date":42,"type":21},"2026-07-31",{"name":44,"class":45},"Frieder Schaumburg","OTHER",""]