IL-10 Stratifying Tool for Towards Antibiotic Selection for MRSaB

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: All

Summary

Patients with MRSaB have high therapeutic failure rates and mortality rates. Recent studies have shown that an elevated IL-10 level is an independent risk factor of mortality. It may also serve as biomarker for very early risk stratification. The aim of this study is to compare the outcomes for patients with elevated IL-10 levels (≥8 pg/ml) when treated with standard antibiotic therapy (daptomycin or vancomycin) versus early aggressive therapy (daptomycin with ceftaroline) for the treatment of MRSaB.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sharp HealthCare
• Treatments: Anti-Bacterial Agents; Ceftaroline fosamil; Daptomycin; Vancomycin

Criteria

Inclusion Criteria:

• Adult (≥ 18 years of age) men or women.

• Diagnosis of MRSaB

• Has not been treated with antibiotics for MRSaB within 7 days of admission

• Has been on standard antibiotics for < 72hrs prior to randomization

• In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy.

Exclusion Criteria:

• Medical history of hypersensitivity or allergic reaction to vancomycin, or vancomycin derivatives, daptomycin or ceftaroline

• Severe allergy to cephalosporins, i.e. Type 1 reaction, especially IgE mediated anaphylaxis

• Comfort care patients

• Death within 72hrs of the start of antibiotic therapy

• Polymicrobial bacteremia: Staphylococcus aureus and another gram positive, gram negative or anaerobic pathogen

• Burns covering ≥ 10% of body.

• Pt currently enrolled in an investigational study