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

NCT05899140 | Recruiting Phase 4 DMC

• 1 other identifier: SoTiClin
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Infection; Staphylococcal Infections; Staphylococcus Aureus Infection

Keywords

SSTI; Staphylococcus aureus; Panton-Valentine leukocidin

Outcome Measures

Primary Outcomes (1)

• Clinical cure at follow-up 7 days

  Proportion of patients with clinical cure defined as the absence of clinical failure

  Day 7

Secondary Outcomes (7)

• 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

Study Arms (2)

Standard of care

OTHER

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

Other: Standard of care

Standard of care + clindamycin

ACTIVE COMPARATOR

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.

Drug: Clindamycin; Other: Standard of care

Interventions

Clindamycin DRUG

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

Standard of care + clindamycin

Standard of care OTHER

Standard of care

Standard of care; Standard of care + clindamycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Frieder Schaumburg: lead

Study Sites (1)

Masanga Hospital

Masokori, Sierra Leone

RECRUITING

MeSH Terms

Conditions

Cellulitis; Staphylococcal Infections

Interventions

Clindamycin; Standard of Care

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Frieder Schaumburg, MD

  Universität Münster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frieder Schaumburg, MD

CONTACT

+492518352767; frieder.schaumburg@ukmuenster.de

Ioana D Olaru, PhD

CONTACT

ioanadiana.olaru@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an exploratory study and will not use a placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor

Model Details: 2-arm randomized controlled trial

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 12, 2023
• Study Start: March 15, 2024
• Primary Completion: March 29, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SI (1)