Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05899140

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

Led by Frieder Schaumburg · Updated on 2024-12-09

100

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (age �3e=18 years)
  • Require treatment (incision/drainage with or without oral or intravenous antibiotics) for a skin or soft tissue infection
  • Infection caused by Staphylococcus aureus confirmed from at least one clinical specimen
  • Symptoms started within the last 4 weeks
  • Randomisation possible within 72 hours after initial culture collection
  • Ability to attend follow-up visits during admission or at home
  • Initial culture collected within 48 hours of hospital admission
  • Willing to participate in the study
Not Eligible

You will not qualify if you...

  • Previous allergic reaction to clindamycin
  • Prior antibiotic-associated diarrhea
  • Previous participation in this study
  • Confirmed pregnancy by beta-HCG rapid test
  • Started clindamycin treatment before clinic visit
  • Systemic antibiotic treatment within the last 14 days
  • Use of other protein synthesis inhibitors (e.g., macrolides, rifampicin, linezolid, aminoglycosides, tetracyclines, chloramphenicol)
  • Use of toxin inducers such as trimethoprim-sulfamethoxazole
  • Severe illness with expected death within 24 hours
  • Chronically infected wounds with symptoms longer than 4 weeks
  • Infections from human or animal bites, prosthetic devices, bedsores, diabetic or peripheral artery disease ulcers, suspected Buruli ulcer, or infected burns
  • Hospital-acquired infections including post-surgical site infections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Masanga Hospital

Masokori, Sierra Leone

Actively Recruiting

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Research Team

F

Frieder Schaumburg, MD

CONTACT

I

Ioana D Olaru, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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