Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

• Status: Completed
• Trial end date: 2015-04-15
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy.

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

Details

• Lead Sponsor: Juan A. Arnaiz
• Treatments: Fosfomycin; Imipenem; Vancomycin

Criteria

Inclusion Criteria:

• Suspected methicillin-resistant staphyloccocus aureus infective endocarditis on a native valve, prosthetic valve or pacemakers´s electrode or defibrillators with definitive or probable diagnosis by the modified Duke criteria (Li J, et al. Clin Infect Dis. 2000).

• Patients over 18 years.

Exclusion Criteria:

• Patients who did not sign informed consent.

• Patients with active consumption intravenous drug.

• Patients with emergent surgery criteria (<72 hours).

• Patients or cardiogenic shock.

• Patients with antibiotic active against MRSA over 72 hours or they may need another antibiotic active against MRSA than those in the study.

• Patients with chronic renal failure on hemodialysis who received empirical treatment with vancomycin as a single dose and have a valley ≥ 15 mcg / mL on the third day.

• Patients with MRSA strains resistant to fosfomycin (MIC> 64 mg / L) (<10%) or vancomycin (MIC> 2 mg / L) or with an MIC to vancomycin of 2 mg / L.

• Patients with any formal contraindication to be treated with study drugs

• Patients treated with any investigational drug within 30 days prior to entering the study.