Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

Infective Endocarditis Clinical Trial

Official title:

Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871104
• Other study ID #: FOSIMI
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2009
• Last updated: March 7, 2018
• Start date: July 2009
• Est. completion date: April 15, 2015

Study information

• Verified date: March 2018
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 15, 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

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

Locations

Country	Name	City	State
Spain	Fundación Hospital Alcorcón	Alcorcón - Madrid	Madrid
Spain	Hospital Bellvitge of Barcelona	Barcelona	Catalonia
Spain	Hospital Clínic of Barcelona	Barcelona	Catalonia
Spain	Hospital Sant Pau of Barcelona	Barcelona	Catalonia
Spain	Hospital de Cruces	Bilbao	Vizcaya
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with negative blood cultures.		7 days
Secondary	Toxicity due to treatment		20 weeks