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NCT02582203 · ClinicalTrials.gov registry record · Phase 4
Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA
A Phase 4 study, sponsored by Wayne State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 174
- Enrollment target
NCT02582203: Completed Phase 4 study, sponsored by Wayne State University.
NCT02582203 is a Phase 4 study that has completed, run by Wayne State University. The registered enrollment target is 174 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02582203, a Phase 4 study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 174 participants
- Enrollment target
Study Summary
The proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John Medical Center in Detroit Michigan with a documented ABSSSI between April 2012 and November 2015 will be evaluated for inclusion. Patients must present with at least 3 of the following local signs/symptoms: pain, tenderness, swelling erythema, warmth, drainage/discharge, induration, and lymph node swelling/tenderness. Patients will be randomized 1:1 ceftaroline or vancomycin with optional anaerobic and/or Gram-negative coverage. The assignment of study drug will follow a randomized list that was previously generated via a computerized random mix block generator (nQuery Advisor® 7.0) and available at each of the study sites. Patients will be randomized to ceftaroline intravenously at 600 mg infused over 1 hour every 12 hours for patients with normal renal function. Patients randomized to vancomycin will receive the standard 15 mg/kg dose based on total body weight infused over 1 hour q 12 hour, dose and interval adjusted based on creatinine clearance and via institution-specific pharmacy protocol to target serum trough concentrations of 10-20 mg/L within the first 72 hours. Outcomes measured in the Clinically Evaluable patient population include day two or three size reduction (percentage) and clinical response at end of therapy or discharge.
Primary Outcome
Reduction of lesion size from baseline of at least 20%
Interventions
- DRUG Vancomycin
- DRUG Ceftaroline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 4 |
What the finished NCT02582203 record still lists
NCT02582203 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.
NCT02582203 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02582203 about?
NCT02582203 is a clinical study titled "Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA". The proposed study is a prospective, open-label, randomized, multi-center trial of ceftaroline versus vancomycin for the treatment of ABSSSI in patients documented or at risk for MRSA. Patients admitted to the Detroit Medical Center, Henry Ford Hospital, or St. John Medical Center in Detroit Michiga...
What is the current status of trial NCT02582203?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 174 participants. The study started on 2012-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02582203?
The interventions under investigation include: Vancomycin (DRUG), Ceftaroline (DRUG).
Who is sponsoring clinical trial NCT02582203?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02582203's enrollment target sits among peer trials
174 480th of 2000 higher than 1,520 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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