Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections

Abscess Clinical Trial

Official title:

Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute S. Aureus Skin and Skin Structure Infections in Patients With Comorbid Conditions: A Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01619410
• Other study ID #: 11-0550
• Status: Terminated
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2019
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abscess
• Skin Diseases
• Skin Diseases, Bacterial

Intervention

Biological:
• Linezolid
Linezolid 600 mg every 12 hours for 7 days
• Clindamycin
Clindamycin 300 mg po every 6 hours for 7 days

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin	Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.	40 days after completion of treatment
Secondary	Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days	The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.	7 days after completion of treatment
Secondary	Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days	The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.	40 days after completion of treatment
Secondary	The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment	The genotype of Staphylococcus aureus which is found to be the cause of the skin infection will be be compared to the genotype of Staphylococcus aureus present after treatment. Comparisons will will be made between the linezolid and clindamycin treatment groups.	40 days after completion of treatment