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Skin Diseases, Bacterial | Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

Skin Diseases, Bacterial research study

What is the primary objective of this study?

In this pilot study, the objective is to determine the prevalence of asymptomatic carriage of S. aureus in patients with ABSSSIs and minor cutaneous abscesses after therapy with either linezolid or clindamycin at 40 days after the completion of therapy. Secondarily, the investigators will assess the efficacy of linezolid vs. clindamycin in the empiric therapy of ABSSSIs and minor cutaneous abscesses, as well as the genotypic spectrum of S. aureus isolates causing ABSSSIs or minor cutaneous abscesses and colonization in the target patient population before and after therapy. Given the results of a recent study on linezolid and vancomycin and the investigator's own experience, it is hypothesized that persistent MRSA carriage will be less common after therapy with linezolid for ABSSSIs and minor cutaneous abscesses than it is with oral clindamycin.

Who is eligible to participate?

Inclusion Criteria: - having an ABSSSI or a minor cutaneous abscess treated in the ED - age 18 years or older - any one or more of the following co-morbidities: - diagnosis of diabetes mellitus - obesity with a BMI >35 - chronic kidney disease - coronary artery disease - peripheral vascular disease Exclusion Criteria: - known history of or current thrombocytopenia - Currently taking anti-depression medication - Current or recent hospitalization - Known current alcohol or drug abuse - Known or suspected hypersensitivity to any ingredient of the study drugs - Irregular heart rate and blood pressure measurements - Fevers or low body temperature - Known psychiatric condition - Superficial skin infection - Skin infection caused from an animal bite - Recent treatment with antibacterials - Pregnancy Other protocol related inclusion/exclusion criteria may apply.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Skin Diseases, Bacterial

Abscess

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:LinezolidLinezolid 600 mg every 12 hours for 7 days

Biological:ClindamycinClindamycin 300 mg po every 6 hours for 7 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

linezolid

Clindamycin

Study Status

Completed

Start Date: January 2012

Completed Date: December 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The presence of Staphylococcus aureus after treatment with linezolid versus clindamycin

Secondary Outcome: Clinical response of skin infections to treatment

Study sponsors, principal investigator, and references

Principal Investigator: Michael Z David, MD, PhD

Lead Sponsor: University of Chicago

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT01619410

Discuss Clindamycin