Actively Recruiting
Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial
Led by Frieder Schaumburg · Updated on 2024-12-09
100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of adding clindamycin to the usual treatment of skin and soft tissue infections caused by Staphylococcus aureus in patients from Sierra Leone. The study aims to see if this combination leads to faster healing and fewer infection recurrences. These infections can be severe due to toxins produced by the bacteria, and clindamycin is believed to reduce these toxins. The trial compares standard treatment, usually involving anti-staphylococcal penicillin with or without surgery to drain infection, to the same treatment plus clindamycin. Clindamycin is given either orally or intravenously for 7 days, with dosing adjusted by weight. Participants receive either the standard care alone or the standard care plus clindamycin, and the study is open-label, meaning both patients and doctors know which treatment is given. Participants will be adults with confirmed Staphylococcus aureus skin infections who require systemic therapy. They will be monitored for clinical cure at 7 and 14 days, changes in inflammation, symptom resolution time, possible side effects, microbiological failure, and infections returning over 6 months. Follow-up visits may occur during hospital admission or at home, and safety and treatment outcomes will be carefully tracked throughout the study period.
CONDITIONS
Brief Title
Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older
- Need treatment (incision/drainage with or without antibiotics) for skin and soft tissue infection
- Infection caused by Staphylococcus aureus confirmed from at least one clinical specimen
- Symptom onset within the last 4 weeks
- Randomisation possible within 72 hours after collection of initial culture
- Ability to attend follow-up visits during admission or at home
- Initial culture collected within 48 hours of hospital admission
- Willingness to participate in the study
You will not qualify if you...
- Allergic reaction to clindamycin
- Previous antibiotic-associated diarrhea
- Previous participation in this study
- Pregnancy confirmed by beta-HCG test
- Started clindamycin treatment before clinic visit
- Systemic antibiotic treatment within the previous 14 days
- Use of other protein synthesis inhibitors (e.g., macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol)
- Use of toxin inducers (trimethoprim-sulfamethoxazole)
- Severe illness expected to cause death within 24 hours
- Chronic wounds with symptoms lasting more than 4 weeks
- Infections from human or animal bites, prosthetic devices, decubitus ulcers, diabetic foot ulcers, Buruli ulcer, or burns
- Hospital-acquired infections including post-surgical site infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days from randomisation
Participants receive either standard of care treatment or standard of care plus adjunctive clindamycin for skin and soft tissue infections.
Daily visits or assessments during treatment period
Duration - Up to 14 days after treatment
Participants are monitored for clinical cure, symptom resolution, adverse events, microbiological outcomes, and recurrence of infection.
Follow-up visits on Day 7 and Day 14
Duration - 6 months passive follow-up
Participants are passively monitored for recurrent infections by re-presentation to clinic.
No scheduled visits; monitoring occurs if participant returns to clinic
Trial Site Locations
Total: 1 location
1
Masanga Hospital
Masokori, Sierra Leone
Actively Recruiting
Research Team
F
Frieder Schaumburg, MD
I
Ioana D Olaru, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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