Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial (SoTiClin)
Skin Infection, Staphylococcal Infections, Staphylococcus Aureus Infection
About this trial
This is an interventional treatment trial for Skin Infection focused on measuring SSTI, Staphylococcus aureus, Panton-Valentine leukocidin
Eligibility Criteria
Inclusion Criteria: Adults (age ≥18 years); Need for a treatment (incision/drainage ± antibiotic treatment po or iv) of an SSTI; 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); Onset of symptoms within the last 4 weeks; Randomisation possible within 72 hours from collection of the initial culture Ability to conduct the follow-up visits either during admission or at home Initial culture collected within 48 hours of hospital admission Willingness to participate in the study. Exclusion Criteria Previous allergic reaction to clindamycin Previous antibiotic-associated diarrhea Previous study participation Pregnancy as confirmed by a beta-HCG rapid test. Started treatment with clindamycin prior to clinic presentation; Documented systemic antibiotic treatment within the previous 14 days Co-administration of other protein synthesis inhibitors (e.g. macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol); Co-administration of toxin inducers (trimethoprim-sulfamethoxazole) Severe illness (patient expected to die in the following 24 hrs); Chronically infected wounds (>4 weeks of symptoms); 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. Hospital-acquired infection including post-surgical site infections
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Other
Active Comparator
Standard of care
Standard of care + clindamycin
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. Treatment 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
Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous). Addition of clindamycin: 10 mg/kg/dose QID iv (maximum 600mg QID iv) or oral clindamycin 450 mg TDS for adults for a total of 7 days from randomisation.