Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

J

Juan A. Arnaiz

Status and phase

Completed
Phase 4

Conditions

Infective Endocarditis

Treatments

Drug: Vancomycin
Drug: Fosfomycin and imipenem

Study type

Interventional

Funder types

Other

Identifiers

NCT00871104
EudraCT number: 2008-008683-28
FOSIMI

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

1
Experimental group
Description:
IV fosfomycin and imipenem adjusted to renal function
Treatment:
Drug: Fosfomycin and imipenem
2
Active Comparator group
Description:
IV Vancomycin twice a day with valley leves higher than 15 mcg/kg
Treatment:
Drug: Vancomycin

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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