Using clindamycin to improve treatment of skin infections caused by Staphylococcus aureus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.