Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

Phase 4

Completed

• Conditions: Infective Endocarditis
• Interventions: Drug: Fosfomycin and imipenem; Drug: Vancomycin

• Registration Number: NCT00871104
• Lead Sponsor: Juan A. Arnaiz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-27
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Study Start: 2009-07
• Primary Completion: 2014-07
• Study Completion: 2015-04-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fosfomycin and imipenem	IV fosfomycin and imipenem adjusted to renal function
2	Vancomycin	IV Vancomycin twice a day with valley leves higher than 15 mcg/kg

Primary Outcome Measures

Name	Time	Method
Proportion of patients with negative blood cultures.	7 days

Secondary Outcome Measures

Name	Time	Method
Toxicity due to treatment	20 weeks

Trial Locations

Locations (10)

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Clínic of Barcelona; 🇪🇸 Barcelona, Catalonia, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Sant Pau of Barcelona; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Fundación Hospital Alcorcón; 🇪🇸 Alcorcón - Madrid, Madrid, Spain

Hospital de Cruces; 🇪🇸 Bilbao, Vizcaya, Spain

Hospital Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Bellvitge of Barcelona; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain