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Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

This study is currently recruiting participants.
Verified February 2013 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00871104
First received: March 27, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes

March 27, 2009
February 21, 2013
July 2009
July 2013   (final data collection date for primary outcome measure)
Proportion of patients with negative blood cultures. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00871104 on ClinicalTrials.gov Archive Site
Toxicity due to treatment [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
July 2013   (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.
Both
18 Years and older
No
Contact: Ana Cruceta, MD 0034932279838 acruceta@clinic.ub.es
Contact: Asunción Moreno Camacho, MD 0034932275586 amoreno@clinic.ub.es
Spain
 
NCT00871104
FOSIMI, EudraCT number: 2008-008683-28
Yes
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
February 2013

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