NCT00871104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2015

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

5 years

First QC Date

March 27, 2009

Last Update Submit

March 7, 2018

Conditions

Infective Endocarditis

Keywords

Infective endocarditis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with negative blood cultures.

    7 days

Secondary Outcomes (1)

  • Toxicity due to treatment

    20 weeks

Study Arms (2)

1

EXPERIMENTAL

IV fosfomycin and imipenem adjusted to renal function

Drug: Fosfomycin and imipenem

2

ACTIVE COMPARATOR

IV Vancomycin twice a day with valley leves higher than 15 mcg/kg

Drug: Vancomycin

Interventions

Fosfomycin and imipenemDRUG

IV Fosfomycin 2 gr./6 hours and IV Imipenem 1 gr./6 hours adjusted acoording to renal function during 4-8 weeks

1
VancomycinDRUG

IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital Sant Pau of Barcelona

Barcelona, Catalonia, 08025, Spain

Location

Hospital Clínic of Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital Bellvitge of Barcelona

Barcelona, Catalonia, 08907, Spain

Location

Fundación Hospital Alcorcón

Alcorcón - Madrid, Madrid, 28922, Spain

Location

Hospital de Cruces

Bilbao, Vizcaya, 48903, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Virgen Macarena

Seville, 410071, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Related Publications (4)

  • Pericas JM, Hernandez-Meneses M, Munoz P, Martinez-Selles M, Alvarez-Uria A, de Alarcon A, Gutierrez-Carretero E, Goenaga MA, Zarauza MJ, Falces C, Rodriguez-Esteban MA, Hidalgo-Tenorio C, Hernandez-Cabrera M, Miro JM; Spanish Collaboration on Endocarditis-Grupo de Apoyo al Manejo de la Endocarditis Infecciosa en Espana (GAMES). Characteristics and Outcome of Acute Heart Failure in Infective Endocarditis: Focus on Cardiogenic Shock. Clin Infect Dis. 2021 Sep 7;73(5):765-774. doi: 10.1093/cid/ciab098.

    PMID: 33560404DERIVED

  • Pericas JM, Ambrosioni J, Munoz P, de Alarcon A, Kestler M, Mari-Hualde A, Moreno A, Goenaga MA, Farinas MC, Rodriguez-Alvarez R, Ojeda-Burgos G, Galvez-Acebal J, Hidalgo-Tenorio C, Noureddine M, Miro JM; GAMES Investigators. Prevalence of Colorectal Neoplasms Among Patients With Enterococcus faecalis Endocarditis in the GAMES Cohort (2008-2017). Mayo Clin Proc. 2021 Jan;96(1):132-146. doi: 10.1016/j.mayocp.2020.06.056.

    PMID: 33413809DERIVED

  • Pericas JM, Llopis J, Munoz P, Galvez-Acebal J, Kestler M, Valerio M, Hernandez-Meneses M, Goenaga MA, Cobo-Belaustegui M, Montejo M, Ojeda-Burgos G, Sousa-Regueiro MD, de Alarcon A, Ramos-Martinez A, Miro JM; GAMES Investigators. A Contemporary Picture of Enterococcal Endocarditis. J Am Coll Cardiol. 2020 Feb 11;75(5):482-494. doi: 10.1016/j.jacc.2019.11.047.

    PMID: 32029130DERIVED

  • del Rio A, Gasch O, Moreno A, Pena C, Cuquet J, Soy D, Mestres CA, Suarez C, Pare JC, Tubau F, Garcia de la Maria C, Marco F, Carratala J, Gatell JM, Gudiol F, Miro JM; FOSIMI Investigators. Efficacy and safety of fosfomycin plus imipenem as rescue therapy for complicated bacteremia and endocarditis due to methicillin-resistant Staphylococcus aureus: a multicenter clinical trial. Clin Infect Dis. 2014 Oct 15;59(8):1105-12. doi: 10.1093/cid/ciu580. Epub 2014 Jul 21.

    PMID: 25048851DERIVED

MeSH Terms

Conditions

Endocarditis

Interventions

FosfomycinImipenemVancomycin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsThienamycinsCarbapenemsbeta-LactamsLactamsAmidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Asunción Moreno Camacho, MD

    Hospital Clínic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 27, 2009

First Posted

March 30, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2014

Study Completion

April 15, 2015

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

ES(10)