Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

This study is currently recruiting participants.

Verified December 2010 by Hospital Clinic of Barcelona

First Received on March 27, 2009. Last Updated on December 14, 2010 History of Changes

Sponsor:	Hospital Clinic of Barcelona
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00871104

Purpose

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.

Condition	Intervention	Phase
Infective Endocarditis	Drug: Fosfomycin and imipenem Drug: Vancomycin	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.

Resource links provided by NLM:

MedlinePlus related topics: Endocarditis

Drug Information available for: Fosfomycin Imipenem Fosfomycin tromethamine Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Proportion of patients with negative blood cultures. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity due to treatment [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	July 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 IV fosfomycin and imipenem adjusted to renal function	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
Active Comparator: 2 IV Vancomycin twice a day with valley leves higher than 15 mcg/kg	Drug: Vancomycin IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871104

Contacts

Contact: Ana Cruceta, MD	0034932279838	acruceta@clinic.ub.es
Contact: Asunción Moreno Camacho, MD	0034932275586	amoreno@clinic.ub.es

Locations

Spain
Hospital Clínic of Barcelona	Enrolling by invitation
Barcelona, Catalonia, Spain, 08036
Hospital Sant Pau of Barcelona	Recruiting
Barcelona, Catalonia, Spain, 08025
Contact: Mercè Gurguí Ferrer, MD 932919000 ext 5624 mgurgui@santpau.es
Hospital Bellvitge of Barcelona	Recruiting
Barcelona, Catalonia, Spain, 08907
Contact: Carmen Peña Miralles, MD 932607625 ext 2488 cpena@bellvitgehospital.cat
Fundación Hospital Alcorcón	Recruiting
Alcorcón - Madrid, Madrid, Spain, 28922
Contact: Juan E Losa García, MD 916219513 JELosa@fhalcorcon.es
Hospital de Cruces	Recruiting
Bilbao, Vizcaya, Spain, 48903
Contact: Miguel Montejo Baranda, MD 917277099 jrpano.hulp@salud.madrid.org
Hospital Gregorio Marañón	Recruiting
Madrid, Spain, 28007
Contact: Patricia Muñoz García, MD 609.22.78.84 pmunoz@micro.hggm.es
Hospital La Paz	Recruiting
Madrid, Spain, 28046
Contact: José R Paño Pardo, MD 917277099 jrpano.hulp@salud.madrid.org
Hospital Ramón y Cajal	Recruiting
Madrid, Spain, 28034
Contact: Enrique Navas Elorza, MD 91 336 8709 enavase@gmail.com
Hospital Virgen Macarena	Recruiting
Sevilla, Spain, 410071
Contact: Juan Gálvez Acebal, MD 955008636 jga@us.es
Hospital Virgen del Rocío	Recruiting
Sevilla, Spain, 41013
Contact: Arístides de Alarcón González, MD 95 501 2375 aa2406ge@yahoo.es

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Principal Investigator:

Asunción Moreno Camacho, MD

Hospital Clínic of Barcelona

More Information

No publications provided

Responsible Party:	Asunción Moreno Camacho, Servicio de Enfermedades Infecciosas. Hospital Clínic
ClinicalTrials.gov Identifier:	NCT00871104 History of Changes
Other Study ID Numbers:	FOSIMI, EudraCT number: 2008-008683-28
Study First Received:	March 27, 2009
Last Updated:	December 14, 2010
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:

Infective endocarditis

Additional relevant MeSH terms:

Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection

Fosfomycin
Imipenem
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012