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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 is a Phase 4 study that has completed, run by Wayne State University. The registered enrollment target is 174 participants.
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.
Interventions
- DRUG Vancomycin
- DRUG Ceftaroline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02582203
The ClinicalTrials.gov registry entry for NCT02582203 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.
NCT02582203 reports 0 study locations.
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.
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