Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

Launched by FRIEDER SCHAUMBURG · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a medication called clindamycin to help treat skin and soft tissue infections caused by a bacteria called Staphylococcus aureus in patients in Sierra Leone. The researchers believe that adding clindamycin to standard treatment may help patients recover more quickly and reduce the chances of the infection coming back.

To be eligible for this study, participants need to be adults aged 18 or older who have a specific type of skin infection and need treatment. They must have had symptoms for less than four weeks and be able to start the study within 72 hours of their initial test. Participants should also be able to attend follow-up visits during their hospital stay or at home. It's important to note that there are some criteria that would exclude someone from participating, such as previous allergic reactions to clindamycin or certain serious health issues. If someone joins the study, they can expect to receive either the standard treatment or the standard treatment plus clindamycin, and they will be monitored closely to see how well the treatment works.

Gender

ALL

Eligibility 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