Clinical trial NCT00102947: Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
Official title: An Open Label Phase 4 Trial to Further Evaluate the Pharmacokinetic Profile of Intravenous Daptomycin, and a Comparison of the Safety and Efficacy of Daptomycin Versus Comparator in the Treatment of Adult Patients With Renal Impairment and Complicated Skin and Skin Structure Infections Due, at Least in Part, to Gram-positive Bacteria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Soft Tissue Infections
Keywords: renal impairment
daptomycin
Cubist
complicated skin and skin structure infections
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2005-02-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Augusta
country: United States
facility: Joseph M. Still Research Institute
state: Georgia
city: Minneapolis
country: United States
facility: Infectious Diseases Minneapolis-LTD
state: Minnesota
city: Buffalo
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: AllTrials Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Dayton
country: United States
facility: Wright State University/Veterans Affairs Medical Center
state: Ohio
city: Toledo
country: United States
facility: ID Clinical Research
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: West Reading
country: United States
facility: The Reading Hospital and Medical Center
state: Pennsylvania
Study officials:
References: