Adjunctive Clindamycin Versus Standard of Care for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled, Open-label Superiority Phase 4 Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical cure at follow-up 7 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an exploratory study and will not use a placebo
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Standard of care
Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous). Treatment according to local guidelines = standard of care: usually an anti-staphylococcal penicillin with or without incision and drainage, as required.
Treatment can be with (local guidelines) cloxacillin (non-severe) po 500g QIDfor 5-7 days ceftriaxone (severe infections) 2g iv OD with step-down to cloxacillin po 500 mg QID for a total of 7 days
干预措施: Standard of care (Other)
Standard of care + clindamycin
Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous).
Addition of clindamycin: 10 mg/kg/dose QID iv (maximum 600mg QID iv) or oral clindamycin 450 mg TDS for adults for a total of 7 days from randomisation.
干预措施: Clindamycin (Drug)
Standard of care + clindamycin
Participants with skin and soft-tissue infections requiring systemic treatment (oral or intravenous).
Addition of clindamycin: 10 mg/kg/dose QID iv (maximum 600mg QID iv) or oral clindamycin 450 mg TDS for adults for a total of 7 days from randomisation.
干预措施: Standard of care (Other)
结局指标
主要结局
Clinical cure at follow-up 7 days
时间窗: Day 7
Proportion of patients with clinical cure defined as the absence of clinical failure
次要结局
- Change in inflammatory markers under therapy(from baseline to Day 3 and from baseline to Day 7)
- Time to symptom resolution(during follow-up up to day 14)
- Occurence of adverse events(anytime during follow-up (to day 14))
- Microbiological failure(during follow-up day 3 and day 7)
- Clostridioides difficile associated diarrhoea(during follow-up, up to day 14)
- Recurrent infections(6 months passive follow-up (participant re-presents to clinic))
- Clinical cure at follow-up 14 days(Day 14)
研究者
Frieder Schaumburg
Principal Investigator, Professor
Universität Münster