Status:

RECRUITING

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

Lead Sponsor:

Frieder Schaumburg

Conditions:

Skin Infection

Staphylococcal Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 ...

Detailed 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 be...

Eligibility Criteria

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

Key Trial Info

Start Date :

March 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 31 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05899140

Start Date

March 15 2024

End Date

July 31 2026

Last Update

December 9 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Masanga Hospital

Masokori, Sierra Leone