Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Control… (NCT05899140) | Clinical Trial Compass
RecruitingPhase 4
Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
Sierra Leone100 participantsStarted 2024-03-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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)