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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2008-008683-28 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | IV fosfomycin and imipenem adjusted to renal function |
|
| 2 | Active Comparator | IV Vancomycin twice a day with valley leves higher than 15 mcg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosfomycin and imipenem | Drug | IV Fosfomycin 2 gr./6 hours and IV Imipenem 1 gr./6 hours adjusted acoording to renal function during 4-8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with negative blood cultures. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity due to treatment | 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asunción Moreno Camacho, MD | Hospital Clínic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sant Pau of Barcelona | Barcelona | Catalonia | 08025 | Spain | ||
| Hospital Clínic of Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33560404 | Derived | 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. | |
| 33413809 |
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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005578 | Fosfomycin |
| D015378 | Imipenem |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013845 | Thienamycins |
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| Vancomycin | Drug | IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg |
|
| Barcelona |
| Catalonia |
| 08036 |
| Spain |
| Hospital Bellvitge of Barcelona | Barcelona | Catalonia | 08907 | Spain |
| Fundación Hospital Alcorcón | Alcorcón - Madrid | Madrid | 28922 | Spain |
| Hospital de Cruces | Bilbao | Vizcaya | 48903 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Virgen Macarena | Seville | 410071 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Derived |
| 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. |
| 32029130 | Derived | 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. |
| 25048851 | Derived | 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. |
| D015780 |
| Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |