Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
Information source: Hospital Clinic of Barcelona
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infective Endocarditis
Intervention: Fosfomycin and imipenem (Drug); Vancomycin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s):
Asunción Moreno Camacho, MD, Principal Investigator, Affiliation: Hospital Clínic of Barcelona
Overall contact:
Ana Cruceta, MD, Phone: 0034932279838, Email: acruceta@clinic.ub.es
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.
Clinical Details
Official title: Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-Resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Proportion of patients with negative blood cultures.
Secondary outcome: Toxicity due to treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Ana Cruceta, MD, Phone: 0034932279838, Email: acruceta@clinic.ub.es
Hospital Gregorio Marañón, Madrid 28007, Spain
Hospital Ramón y Cajal, Madrid 28034, Spain
Hospital La Paz, Madrid 28046, Spain
Hospital Virgen del Rocío, Sevilla 41013, Spain
Hospital Virgen Macarena, Sevilla 410071, Spain
Hospital Clínic of Barcelona, Barcelona, Catalonia 08036, Spain
Hospital Sant Pau of Barcelona, Barcelona, Catalonia 08025, Spain
Hospital Bellvitge of Barcelona, Barcelona, Catalonia 08907, Spain
Fundación Hospital Alcorcón, Alcorcón - Madrid, Madrid 28922, Spain
Hospital de Cruces, Bilbao, Vizcaya 48903, Spain
Additional Information
Starting date: July 2009
Ending date: December 2011
Last updated: March 27, 2009
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