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Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

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ClinicalTrials.gov Identifier: NCT00871104
Recruitment Status : Completed
First Posted : March 30, 2009
Last Update Posted : March 8, 2018
Sponsor:
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)
Actual 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
Actual Primary Completion Date : July 2014
Actual Study Completion Date : April 15, 2015


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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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


Locations
Spain
Hospital Sant Pau of Barcelona
Barcelona, Catalonia, Spain, 08025
Hospital Clínic of Barcelona
Barcelona, Catalonia, Spain, 08036
Hospital Bellvitge of Barcelona
Barcelona, Catalonia, Spain, 08907
Fundación Hospital Alcorcón
Alcorcón - Madrid, Madrid, Spain, 28922
Hospital de Cruces
Bilbao, Vizcaya, Spain, 48903
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital La Paz
Madrid, Spain, 28046
Hospital Virgen Macarena
Sevilla, Spain, 410071
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
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: March 8, 2018
Last Verified: March 2018

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

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