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Clinical Trial Summary

Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI


Clinical Trial Description

The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02570490
Study type Interventional
Source Arrevus Inc.
Contact
Status Completed
Phase Phase 3
Start date November 2015
Completion date November 2016

See also
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Completed NCT00949130 - Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 2
Completed NCT03176134 - A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018) Phase 3
Completed NCT03137173 - Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT03405064 - Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 3