Using clindamycin to improve treatment of skin infections caused by Staphylococcus aureus
Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial
This study is testing if adding clindamycin to regular treatment can help adults in Sierra Leone recover faster from skin infections caused by Staphylococcus aureus.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universität Münster Academic / other |
| Locations | 1 site (Masokori) |
| Trial ID | NCT05899140 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of adding clindamycin to standard treatment for skin and soft tissue infections caused by Staphylococcus aureus in patients in Sierra Leone. It aims to determine if clindamycin can lead to faster recovery and fewer recurrences of infection. The trial will include 100 adult participants who have been diagnosed with these infections and will be conducted as an open-label randomized controlled trial at Masanga Hospital. The study will assess the feasibility, efficacy, and safety of this adjunctive therapy compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a recent diagnosis of skin and soft tissue infections due to Staphylococcus aureus.
Not a fit: Patients with a history of allergic reactions to clindamycin or those who have received systemic antibiotics within the past 14 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced recurrence rates for patients with Staphylococcus aureus skin infections.
How similar studies have performed: While the use of clindamycin as an adjunctive treatment is promising, this specific approach is being explored in this novel context and has not been extensively tested in similar settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults (age ≥18 years); 2. Need for a treatment (incision/drainage ± antibiotic treatment po or iv) of an SSTI; 3. 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); 4. Onset of symptoms within the last 4 weeks; 5. Randomisation possible within 72 hours from collection of the initial culture 6. Ability to conduct the follow-up visits either during admission or at home 7. Initial culture collected within 48 hours of hospital admission 8. Willingness to participate in the study. Exclusion Criteria 1. Previous allergic reaction to clindamycin 2. Previous antibiotic-associated diarrhea 3. Previous study participation 4. Pregnancy as confirmed by a beta-HCG rapid test. 5. Started treatment with clindamycin prior to clinic presentation; 6. Documented systemic antibiotic treatment within the previous 14 days 7. Co-administration of other protein synthesis inhibitors (e.g. macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol); 8. Co-administration of toxin inducers (trimethoprim-sulfamethoxazole) 9. Severe illness (patient expected to die in the following 24 hrs); 10. Chronically infected wounds (\>4 weeks of symptoms); 11. 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. 12. Hospital-acquired infection including post-surgical site infections
Where this trial is running
Masokori
- Masanga Hospital — Masokori, Sierra Leone (Recruiting)
Study contacts
- Principal investigator: Frieder Schaumburg, MD — Universität Münster
- Study coordinator: Frieder Schaumburg, MD
- Email: frieder.schaumburg@ukmuenster.de
- Phone: +492518352767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.