Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
NCT ID: NCT00871104
Last Updated: 2018-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2009-07-31
2015-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
IV fosfomycin and imipenem adjusted to renal function
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
2
IV Vancomycin twice a day with valley leves higher than 15 mcg/kg
Vancomycin
IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg
Interventions
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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
Vancomycin
IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Juan A. Arnaiz
OTHER
Responsible Party
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Juan A. Arnaiz
MD, PhD
Principal Investigators
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Asunción Moreno Camacho, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic of Barcelona
Locations
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Hospital Sant Pau of Barcelona
Barcelona, Catalonia, Spain
Hospital Clínic of Barcelona
Barcelona, Catalonia, Spain
Hospital Bellvitge of Barcelona
Barcelona, Catalonia, Spain
Fundación Hospital Alcorcón
Alcorcón - Madrid, Madrid, Spain
Hospital de Cruces
Bilbao, Vizcaya, Spain
Hospital Gregorio Marañón
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Virgen Macarena
Seville, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Countries
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References
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Pericas JM, Hernandez-Meneses M, Munoz P, Martinez-Selles M, Alvarez-Uria A, de Alarcon A, Gutierrez-Carretero E, Goenaga MA, Zarauza MJ, Falces C, Rodriguez-Esteban MA, Hidalgo-Tenorio C, Hernandez-Cabrera M, Miro JM; Spanish Collaboration on Endocarditis-Grupo de Apoyo al Manejo de la Endocarditis Infecciosa en Espana (GAMES). Characteristics and Outcome of Acute Heart Failure in Infective Endocarditis: Focus on Cardiogenic Shock. Clin Infect Dis. 2021 Sep 7;73(5):765-774. doi: 10.1093/cid/ciab098.
Pericas JM, Ambrosioni J, Munoz P, de Alarcon A, Kestler M, Mari-Hualde A, Moreno A, Goenaga MA, Farinas MC, Rodriguez-Alvarez R, Ojeda-Burgos G, Galvez-Acebal J, Hidalgo-Tenorio C, Noureddine M, Miro JM; GAMES Investigators. Prevalence of Colorectal Neoplasms Among Patients With Enterococcus faecalis Endocarditis in the GAMES Cohort (2008-2017). Mayo Clin Proc. 2021 Jan;96(1):132-146. doi: 10.1016/j.mayocp.2020.06.056.
Pericas JM, Llopis J, Munoz P, Galvez-Acebal J, Kestler M, Valerio M, Hernandez-Meneses M, Goenaga MA, Cobo-Belaustegui M, Montejo M, Ojeda-Burgos G, Sousa-Regueiro MD, de Alarcon A, Ramos-Martinez A, Miro JM; GAMES Investigators. A Contemporary Picture of Enterococcal Endocarditis. J Am Coll Cardiol. 2020 Feb 11;75(5):482-494. doi: 10.1016/j.jacc.2019.11.047.
del Rio A, Gasch O, Moreno A, Pena C, Cuquet J, Soy D, Mestres CA, Suarez C, Pare JC, Tubau F, Garcia de la Maria C, Marco F, Carratala J, Gatell JM, Gudiol F, Miro 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.
Other Identifiers
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EudraCT number: 2008-008683-28
Identifier Type: -
Identifier Source: secondary_id
FOSIMI
Identifier Type: -
Identifier Source: org_study_id
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