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Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

Primary Purpose

Infective Endocarditis

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Fosfomycin and imipenem
Vancomycin
Sponsored by
Juan A. Arnaiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infective Endocarditis focused on measuring Infective endocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Sant Pau of Barcelona
  • Hospital Clínic of Barcelona
  • Hospital Bellvitge of Barcelona
  • Fundación Hospital Alcorcón
  • Hospital de Cruces
  • Hospital Gregorio Marañón
  • Hospital Ramón y Cajal
  • Hospital La Paz
  • Hospital Virgen Macarena
  • Hospital Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

IV fosfomycin and imipenem adjusted to renal function

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

Outcomes

Primary Outcome Measures

Proportion of patients with negative blood cultures.

Secondary Outcome Measures

Toxicity due to treatment

Full Information

First Posted
March 27, 2009
Last Updated
March 7, 2018
Sponsor
Juan A. Arnaiz
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1. Study Identification

Unique Protocol Identification Number
NCT00871104
Brief Title
Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis
Official Title
Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
April 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Endocarditis
Keywords
Infective endocarditis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
IV fosfomycin and imipenem adjusted to renal function
Arm Title
2
Arm Type
Active Comparator
Arm Description
IV Vancomycin twice a day with valley leves higher than 15 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Fosfomycin and imipenem
Intervention Description
IV Fosfomycin 2 gr./6 hours and IV Imipenem 1 gr./6 hours adjusted acoording to renal function during 4-8 weeks
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg
Primary Outcome Measure Information:
Title
Proportion of patients with negative blood cultures.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Toxicity due to treatment
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asunción Moreno Camacho, MD
Organizational Affiliation
Hospital Clínic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sant Pau of Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clínic of Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Bellvitge of Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08907
Country
Spain
Facility Name
Fundación Hospital Alcorcón
City
Alcorcón - Madrid
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
410071
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33560404
Citation
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.
Results Reference
derived
PubMed Identifier
33413809
Citation
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.
Results Reference
derived
PubMed Identifier
32029130
Citation
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. Erratum In: J Am Coll Cardiol. 2020 Jun 16;75(23):2998-3000.
Results Reference
derived
PubMed Identifier
25048851
Citation
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.
Results Reference
derived

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Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

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