Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00871104
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

March 27, 2009
March 30, 2009
March 8, 2018
July 2009
July 2014   (Final data collection date for primary outcome measure)
Proportion of patients with negative blood cultures. [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT00871104 on Archive Site
Toxicity due to treatment [ Time Frame: 20 weeks ]
Same as current
Not Provided
Not Provided
Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infective Endocarditis
  • Drug: Fosfomycin and imipenem
    IV Fosfomycin 2 gr./6 hours and IV Imipenem 1 gr./6 hours adjusted acoording to renal function during 4-8 weeks
  • Drug: Vancomycin
    IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg
  • Experimental: 1
    IV fosfomycin and imipenem adjusted to renal function
    Intervention: Drug: Fosfomycin and imipenem
  • Active Comparator: 2
    IV Vancomycin twice a day with valley leves higher than 15 mcg/kg
    Intervention: Drug: Vancomycin
del Río A, Gasch O, Moreno A, Peña C, Cuquet J, Soy D, Mestres CA, Suárez C, Pare JC, Tubau F, Garcia de la Mària C, Marco F, Carratalà J, Gatell JM, Gudiol F, Miró JM; FOSIMI Investigators. Efficacy and safety of fosfomycin plus imipenem as rescue therapy for complicated bacteremia and endocarditis due to methicillin-resistant Staphylococcus aureus: a multicenter clinical trial. Clin Infect Dis. 2014 Oct 15;59(8):1105-12. doi: 10.1093/cid/ciu580. Epub 2014 Jul 21.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 15, 2015
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCT number: 2008-008683-28
Not Provided
Not Provided
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Principal Investigator: Asunción Moreno Camacho, MD Hospital Clínic of Barcelona
Hospital Clinic of Barcelona
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP