Health Trials

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

ConditionsSkin InfectionStaphylococcal InfectionsStaphylococcus Aureus Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrieder Schaumburg

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Previous allergic reaction to clindamycin

Previous antibiotic-associated diarrhea

Previous study participation

Pregnancy as confirmed by a beta-HCG rapid test.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

    Other intervention

    Standard of care

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard of careOther 1 intervention
Group B: Standard of care + clindamycinActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Clinical cure at follow-up 7 days

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

Time frame
Day 7

Secondary outcomes

1

Change in inflammatory markers under therapy

Change in mean C-reactive protein level

Time frame
from baseline to Day 3 and from baseline to Day 7
2

Time to symptom resolution

Time to resolution of symptoms

Time frame
during follow-up up to day 14
3

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

Time frame
anytime during follow-up (to day 14)
4

Microbiological failure

Proportion of microbiological treatment failure (culture of S. aureus in relevant materials) on Day 3 and Day 7;

Time frame
during follow-up day 3 and day 7

Other outcomes

Sponsors and contacts

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Frieder Schaumburg

Lead sponsor

Universität Münster

Sponsor institution

Source ClinicalTrials.gov
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