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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05899140
Other study ID # SoTiClin
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date February 1, 2024
Est. completion date July 31, 2024

Study information

Verified date December 2023
Source Westfälische Wilhelms-Universität Münster
Contact Frieder Schaumburg, MD
Phone +492518352767
Email frieder.schaumburg@ukmuenster.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 31, 2024
Est. primary completion date March 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adults (age =18 years); 2. Need for a treatment (incision/drainage ± antibiotic treatment po or iv) of an SSTI; 3. 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); 4. Onset of symptoms within the last 4 weeks; 5. Randomisation possible within 72 hours from collection of the initial culture 6. Ability to conduct the follow-up visits either during admission or at home 7. Initial culture collected within 48 hours of hospital admission 8. Willingness to participate in the study. Exclusion Criteria 1. Previous allergic reaction to clindamycin 2. Previous antibiotic-associated diarrhea 3. Previous study participation 4. Pregnancy as confirmed by a beta-HCG rapid test. 5. Started treatment with clindamycin prior to clinic presentation; 6. Documented systemic antibiotic treatment within the previous 14 days 7. Co-administration of other protein synthesis inhibitors (e.g. macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol); 8. Co-administration of toxin inducers (trimethoprim-sulfamethoxazole) 9. Severe illness (patient expected to die in the following 24 hrs); 10. Chronically infected wounds (>4 weeks of symptoms); 11. 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. 12. Hospital-acquired infection including post-surgical site infections

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Frieder Schaumburg

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical cure at follow-up 7 days Proportion of patients with clinical cure defined as the absence of clinical failure Day 7
Secondary Change in inflammatory markers under therapy Change in mean C-reactive protein level from baseline to Day 3 and from baseline to Day 7
Secondary Time to symptom resolution Time to resolution of symptoms during follow-up up to day 14
Secondary Occurence of adverse events Proportion of patients with adverse events (of any kind) and of adverse events that required treatment discontinuation or change in drugs used anytime during follow-up (to day 14)
Secondary Microbiological failure Proportion of microbiological treatment failure (culture of S. aureus in relevant materials) on Day 3 and Day 7; during follow-up day 3 and day 7
Secondary Clostridioides difficile associated diarrhoea Proportion with Clostridioides difficile associated diarrhoea during follow-up, up to day 14
Secondary Recurrent infections Proportion of recurrent infections during a passive follow up of 6 months 6 months passive follow-up (participant re-presents to clinic)
Secondary Clinical cure at follow-up 14 days Proportion of patients with clinical cure defined as the absence of clinical failure Day 14
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