Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections
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
2 other identifiers
interventional
72
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2005
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 4, 2005
CompletedFirst Posted
Study publicly available on registry
February 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJuly 25, 2016
July 1, 2016
1.8 years
February 4, 2005
July 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
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
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Harbor UCLA Medical Center
Torrance, California, 90509, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Joseph M. Still Research Institute
Augusta, Georgia, United States
Infectious Diseases Minneapolis-LTD
Minneapolis, Minnesota, 55422, United States
Upstate Clinical Research Associates
Buffalo, New York, 14203, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
AllTrials Clinical Research
Winston-Salem, North Carolina, 27103, United States
Riverside Methodist Hospital
Columbus, Ohio, 43215, United States
Wright State University/Veterans Affairs Medical Center
Dayton, Ohio, 45428, United States
ID Clinical Research
Toledo, Ohio, 43608, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 19015, United States
The Reading Hospital and Medical Center
West Reading, Pennsylvania, 19610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2005
First Posted
February 7, 2005
Study Start
January 1, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
July 25, 2016
Record last verified: 2016-07