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Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

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ClinicalTrials.gov Identifier: NCT00871104
Recruitment Status : Unknown
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : March 30, 2009
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
Infective Endocarditis Drug: Fosfomycin and imipenem Drug: Vancomycin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : July 2009
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Proportion of patients with negative blood cultures. [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Toxicity due to treatment [ Time Frame: 20 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871104

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

Hospital Sant Pau of Barcelona Recruiting
Barcelona, Catalonia, Spain, 08025
Contact: Mercè Gurguí Ferrer, MD    932919000 ext 5624    mgurgui@santpau.es   
Hospital Clínic of Barcelona Enrolling by invitation
Barcelona, Catalonia, Spain, 08036
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 Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Enrique Navas Elorza, MD    91 336 8709    enavase@gmail.com   
Hospital La Paz Recruiting
Madrid, Spain, 28046
Contact: José R Paño Pardo, MD    917277099    jrpano.hulp@salud.madrid.org   
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
Juan A. Arnaiz
Principal Investigator: Asunción Moreno Camacho, MD Hospital Clínic of Barcelona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00871104     History of Changes
Other Study ID Numbers: FOSIMI
EudraCT number: 2008-008683-28
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
Infective endocarditis

Additional relevant MeSH terms:
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Anti-Bacterial Agents
Anti-Infective Agents