Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clindamycin, Standard of care.
- Who it may be relevant to
- Registry conditions: Skin Infection, Staphylococcal Infections, Staphylococcus Aureus Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sierra Leone
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial
Overview
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.
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 beneficial, due to the major role of protein-toxins in the pathogenesis of skin and soft tissue infections. Clindamycin has a strong toxin-suppressive activity. Therefore, clindamycin is currently considered as the most-promising adjuvant antimicrobial agent in the treatment of toxin-mediated S. aureus infections. Recurrent infections are common in patients with S. aureus skin and soft-tissue infections. Clindamycin has been reported to reduce S. aureus colonisation, which may in turn reduce the risk for recurrent infections. Clindamycin is an already approved antimicrobial used for a wide range of indications and with a known safety profile.
This study is an investigator-led, investigator-initiated, open-label superiority randomised controlled trial that will be conducted at Masanga Hospital in Sierra Leone. The objectives of this study are to determine the feasibility, efficacy and safety of adjunctive clindamycin therapy (in addition to standard-of-care) compared to standard-of-care alone on clinical treatment outcomes in patients with skin and soft tissue infections due to S. aureus in Sierra Leone. This is a preliminary study, which will include 100 adult participants with skin and soft-tissue infections requiring systemic therapy.
Interventions
- Drug Clindamycin
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 - Other Standard of care
Standard of care
Primary outcome measures
- Clinical cure at follow-up 7 days [Time frame: Day 7]
Secondary outcome measures (7)
- Change in inflammatory markers under therapy [Time frame: from baseline to Day 3 and from baseline to Day 7]
- Time to symptom resolution [Time frame: during follow-up up to day 14]
- Occurence of adverse events [Time frame: anytime during follow-up (to day 14)]
- Microbiological failure [Time frame: during follow-up day 3 and day 7]
- Clostridioides difficile associated diarrhoea [Time frame: during follow-up, up to day 14]
- Recurrent infections [Time frame: 6 months passive follow-up (participant re-presents to clinic)]
- Clinical cure at follow-up 14 days [Time frame: Day 14]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sierra Leone · 1 center
- Masanga Hospital — Masokori
Identifiers
NCT: NCT05899140 · SoTiClin