Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899140
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-05-22
Brief Title:
Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections a Randomized Controlled Trial
Sponsor:
Frieder Schaumburg
Organization:
Universität Münster
Study Overview
Official Title:
Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections a Randomized Controlled Open-label Superiority Phase 4 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SoTiClin
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None