Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014