Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections - Tabular View

Tracking Information
First Received Date ^ICMJE	February 4, 2005
Last Updated Date	May 21, 2007
Start Date ^ICMJE	January 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To obtain additional pharmacokinetic data (on dosing days) on intravenous daptomycin in patients with complicated skin and skin structure infections and renal impairment
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00102947 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Condition ^ICMJE	Soft Tissue Infections
Intervention ^ICMJE	Drug: daptomycin (up to 14 days)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	72
Completion Date	May 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00102947
Responsible Party
Study ID Numbers ^ICMJE	DAP-REN-03-06
Study Sponsor ^ICMJE	Cubist Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cubist Pharmaceuticals
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP