Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00871104

Enrollment

Registered

2009-03-30

Start date

2009-07-31

Completion date

2015-04-15

Last updated

2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infective Endocarditis

Keywords

Infective endocarditis

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.

Interventions

DRUGFosfomycin and imipenem

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

DRUGVancomycin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with negative blood cultures.	7 days

Secondary

Measure	Time frame
Toxicity due to treatment	20 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026