Status:
RECRUITING
Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
Lead Sponsor:
Frieder Schaumburg
Conditions:
Skin Infection
Staphylococcal Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 be...
Eligibility Criteria
Inclusion Criteria:
- Adults (age ≥18 years);
- Need for a treatment (incision/drainage ± antibiotic treatment po or iv) of an SSTI;
- 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);
- Onset of symptoms within the last 4 weeks;
- Randomisation possible within 72 hours from collection of the initial culture
- Ability to conduct the follow-up visits either during admission or at home
- Initial culture collected within 48 hours of hospital admission
- Willingness to participate in the study.
Exclusion Criteria
- Previous allergic reaction to clindamycin
- Previous antibiotic-associated diarrhea
- Previous study participation
- Pregnancy as confirmed by a beta-HCG rapid test.
- Started treatment with clindamycin prior to clinic presentation;
- Documented systemic antibiotic treatment within the previous 14 days
- Co-administration of other protein synthesis inhibitors (e.g. macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol);
- Co-administration of toxin inducers (trimethoprim-sulfamethoxazole)
- Severe illness (patient expected to die in the following 24 hrs);
- Chronically infected wounds (>4 weeks of symptoms);
- 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.
- Hospital-acquired infection including post-surgical site infections
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05899140
Start Date
March 15 2024
End Date
July 31 2026
Last Update
December 9 2024
Active Locations (1)
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1
Masanga Hospital
Masokori, Sierra Leone