Clinical trial NCT00871104: Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
Official title: Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infective Endocarditis
Keywords: Infective endocarditis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients with negative blood cultures.
timeFrame: 7 days
Secondary outcomes:
measure: Toxicity due to treatment
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Pau of Barcelona
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Clínic of Barcelona
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Bellvitge of Barcelona
state: Catalonia
city: Alcorcón - Madrid
country: Spain
facility: Fundación Hospital Alcorcón
state: Madrid
city: Bilbao
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital La Paz
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
Study officials:
affiliation: Hospital Clínic of Barcelona
name: Asunción Moreno Camacho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.