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Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

This study is currently recruiting participants.
Verified February 2013 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00871104
First received: March 27, 2009
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  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 4

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
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 2013
Estimated Primary Completion Date: July 2013 (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
Juan A. Arnaiz
Investigators
Principal Investigator: Asunción Moreno Camacho, MD Hospital Clínic of Barcelona
  More Information

No publications provided

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
Study First Received: March 27, 2009
Last Updated: February 21, 2013
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 May 19, 2013