Asymptomatic Colonization With S. Aureus After Therapy With Linezolid or Clindamycin for Acute Skin Infections
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|ClinicalTrials.gov Identifier: NCT01619410|
Recruitment Status : Terminated (slow accrual)
First Posted : June 14, 2012
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Skin Diseases, Bacterial Abscess||Biological: Linezolid Biological: Clindamycin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
|Active Comparator: linezolid||
Linezolid 600 mg every 12 hours for 7 days
|Active Comparator: Clindamycin||
Clindamycin 300 mg po every 6 hours for 7 days
- The Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin [ Time Frame: 40 days after completion of treatment ]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.
- Clinical Response of Skin Infections to Treatment -- 7 Days [ Time Frame: 7 days after completion of treatment ]The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
- Clinical Response of Skin Infections to Treatment -- 40 Days [ Time Frame: 40 days after completion of treatment ]The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.
- The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment [ Time Frame: 40 days after completion of 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619410
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Michael Z David, MD, PhD||University of Chicago|