Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

Staphylococcal Infections Clinical Trial

— SoTiClin  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05899140
• Other study ID #: SoTiClin
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Cellulitis
• Communicable Diseases
• Infections
• Skin Diseases, Infectious
• Skin Infection
• Soft Tissue Infections
• Staphylococcal Infections
• Staphylococcus Aureus Infection

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