Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
NCT ID: NCT05899140
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-03-15
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Standard of care
Standard of care
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.
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
Standard of care
Standard of care
Interventions
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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
Standard of care
Standard of care
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Frieder Schaumburg
OTHER
Responsible Party
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Frieder Schaumburg
Principal Investigator, Professor
Principal Investigators
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Frieder Schaumburg, MD
Role: PRINCIPAL_INVESTIGATOR
Universität Münster
Locations
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Masanga Hospital
Masokori, , Sierra Leone
Countries
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Central Contacts
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Facility Contacts
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Emmanuel M Kanu, MB BS
Role: primary
Other Identifiers
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SoTiClin
Identifier Type: -
Identifier Source: org_study_id