Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
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|ClinicalTrials.gov Identifier: NCT02276482|
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Skin Diseases, Infectious Skin Diseases, Bacterial||Drug: Tedizolid Phophate 200 mg, IV and/or oral for 6 days Drug: Antibiotic comparator||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 3 Study of IV to Oral 6-Day Tedizolid Phosphate Compared With 10-day Comparator in Subjects 12 to < 18 Years With cSSTI.|
|Actual Study Start Date :||March 25, 2015|
|Actual Primary Completion Date :||September 17, 2018|
|Actual Study Completion Date :||September 17, 2018|
Experimental: Tedizolid Phosphate
IV and/or oral 200 mg once per day for 6 days
Drug: Tedizolid Phophate 200 mg, IV and/or oral for 6 days
Other Name: TR701-122
Active Comparator: Antibiotic comparator drug
IV and/or oral antibiotic comparator drug for 10 days
Drug: Antibiotic comparator
Other Name: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin
- Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs [ Time Frame: Up to 39 days ]The primary objective is to compare the safety of IV and/or oral 6-day 200 mg tedizolid phosphate with 10-day Comparator standard of care in participants 12 to <18 years with cSSTI. Safety will be assessed through summaries of Treatment Emergent Adverse Events by treatment groups (tedizolid phosphate and other comparator drugs).
- Number of Participants with Lesion Reduction Success [ Time Frame: 25 days ]To compare the programmatic early clinical response % in the tedizolid phosphate and comparator groups defined as a >= 20% reduction from baseline lesion area in cm2 of erythema, edema or induration.
- Number of Participants with Investigator's Assessment Indicating Clinical Success [ Time Frame: Treatment to Cure Visit: 18-25 days after first drug infusion ]To compare the Investigator's assessment of clinical success in the tedizolid phosphate and Comparator groups at the Test of Cure (TOC; 18 to 25 days after the first infusion) Visit in the Intent to Treat (ITT) and Clinically Evaluable at TOC (CE-TOC) Analysis Sets.
- Number of Participants with Early Clinical Responses Measured by Lesion Reduction [ Time Frame: 48-72 hours after first drug infusion ]To compare the programmatic early clinical response in the tedizolid phosphate and Comparator groups at the 48-72 Hour Visit in the ITT Analysis Set
- Number of Participants with Investigator's Assessment Indicating Early Clinical Success [ Time Frame: End of Therapy Visit: up to 13 days after first drug infusion ]To compare the Investigator's assessment of clinical success in the tedizolid phosphate and Comparator groups at the End of Therapy (EOT) Visit (Day 11+2) in the ITT and CE-EOT Analysis Sets
- Peak Plasma Concentration (Cmax) of Tedizolid Phosphate [ Time Frame: Day 1, 48-72 hours, Day 7 ]Evaluate peak concentration of tedizolid phosphate after drug administration using validated assay.
- Area Under the Plasma Concentration Versus Time Curve (AUC) of Tedizolid Phosphate [ Time Frame: Day 1, 48-72 hours, Day 7 ]Evaluate systemic plasma concentration of tedizolid phosphate after drug administration using a validated assay.
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): NCT02276482
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|