A Phase 4 interventional study of Clindamycin and Standard of care in Skin Infection, Staphylococcal Infections and Staphylococcus Aureus Infection, sponsored by Frieder Schaumburg. Recruiting at 1 site in Sierra Leone. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Frieder Schaumburg · Phase 4, Interventional, and Treatment
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.
Panton-Valentine Leukokidin and other toxins play an important role in the severity of skin and soft-tissue infections due to Staphylococcus aureus. The inhibition of the protein synthesis could be beneficial, due to the major role of protein-toxins in the pathogenesis of skin and soft tissue infections. Clindamycin has a strong toxin-suppressive activity. Therefore, clindamycin is currently considered as the most-promising adjuvant antimicrobial agent in the treatment of toxin-mediated S. aureus infections. Recurrent infections are common in patients with S. aureus skin and soft-tissue infections. Clindamycin has been reported to reduce S. aureus colonisation, which may in turn reduce the risk for recurrent infections. Clindamycin is an already approved antimicrobial used for a wide range of indications and with a known safety profile.
This study is an investigator-led, investigator-initiated, open-label superiority randomised controlled trial that will be conducted at Masanga Hospital in Sierra Leone. The objectives of this study are to determine the feasibility, efficacy and safety of adjunctive clindamycin therapy (in addition to standard-of-care) compared to standard-of-care alone on clinical treatment outcomes in patients with skin and soft tissue infections due to S. aureus in Sierra Leone. This is a preliminary study, which will include 100 adult participants with skin and soft-tissue infections requiring systemic therapy.
160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's planned enrollment of 100 is below the median of 157 across 124 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →This is the only study on the registry with Frieder Schaumburg as lead sponsor.
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Exclusion Criteria
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
Other: Standard of care
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.
Drug: Clindamycin · Other: Standard of care
Clindamycin will be administered at a dose of 450 mg TDS (oral) or 10 mg/kg/dose QID iv (maximum 600mg QID iv) for a maximum of 7 days
Standard of care
Clinical cure at follow-up 7 days
Proportion of patients with clinical cure defined as the absence of clinical failure
Time frame: Day 7
Change in inflammatory markers under therapy
Change in mean C-reactive protein level
Time frame: from baseline to Day 3 and from baseline to Day 7
Time to symptom resolution
Time to resolution of symptoms
Time frame: during follow-up up to day 14
Occurence of adverse events
Proportion of patients with adverse events (of any kind) and of adverse events that required treatment discontinuation or change in drugs used
Time frame: anytime during follow-up (to day 14)
Microbiological failure
Proportion of microbiological treatment failure (culture of S. aureus in relevant materials) on Day 3 and Day 7;
Time frame: during follow-up day 3 and day 7
Clostridioides difficile associated diarrhoea
Proportion with Clostridioides difficile associated diarrhoea
Time frame: during follow-up, up to day 14
Recurrent infections
Proportion of recurrent infections during a passive follow up of 6 months
Time frame: 6 months passive follow-up (participant re-presents to clinic)
Clinical cure at follow-up 14 days
Proportion of patients with clinical cure defined as the absence of clinical failure
Time frame: Day 14
Plan to share: No — This is currently being considered and the information will be updated once a decision has been reached
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2026, 24 months after the start.
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