Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial
Frieder Schaumburg
100 participants
Mar 15, 2024
INTERVENTIONAL
Conditions
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 hypothesizes that clindamycin, when added to routine treatment, will lead to a more rapid clinical resolution and less frequent recurrences of infection.
Eligibility
Inclusion Criteria8
- 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 Criteria12
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Clindamycin will be administered at a dose of 450 mg TDS (oral) or 10 mg/kg/dose QID iv (maximum 600mg QID iv) for a maximum of 7 days
Standard of care
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05899140