A Phase 4 interventional study of daptomycin (up to 14 days) in Soft Tissue Infections, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Terminated at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-25.
Sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 4, Interventional, and Treatment
This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 72 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 65 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: - Moderate to end-stage renal impairment - A diagnosis of complicated skin and skin structure infection known or suspected to be due to susceptible Gram-positive bacteria based on positive Gram stain - A diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor Exclusion Criteria: - Known bacteremia, osteomyelitis or endocarditis
To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
To compare the safety and efficacy of daptomycin to comparator in patients with complicated skin and skin structure infections and renal impairment at 14 to 21 days after last dose
This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)