Status:
COMPLETED
Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
Lead Sponsor:
Juan A. Arnaiz
Conditions:
Infective Endocarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00871104
Start Date
July 1 2009
End Date
April 15 2015
Last Update
March 8 2018
Active Locations (10)
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1
Hospital Sant Pau of Barcelona
Barcelona, Catalonia, Spain, 08025
2
Hospital Clínic of Barcelona
Barcelona, Catalonia, Spain, 08036
3
Hospital Bellvitge of Barcelona
Barcelona, Catalonia, Spain, 08907
4
Fundación Hospital Alcorcón
Alcorcón - Madrid, Madrid, Spain, 28922