Fosfomycin Plus Imipenem for Treatment of Infective Endocarditis

Sponsor

Juan A. Arnaiz (Other)

Overall Status

Completed

CT.gov ID

NCT00871104

Collaborator

(none)

Enrollment

Locations

Arms

69.5

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infective Endocarditis	Drug: Fosfomycin and imipenem Drug: Vancomycin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Apr 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 IV fosfomycin and imipenem adjusted to renal function	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
Active Comparator: 2 IV Vancomycin twice a day with valley leves higher than 15 mcg/kg	Drug: Vancomycin IV Vancomycin 30 mg/kg twice a day with valley leves higher than 15 mcg/kg

Arm

Intervention/Treatment

Experimental: 1

IV fosfomycin and imipenem adjusted to renal function

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

Active Comparator: 2

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

Drug: Vancomycin

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

Outcome Measures

Primary Outcome Measures

Proportion of patients with negative blood cultures. [7 days]

Secondary Outcome Measures

Toxicity due to treatment [20 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Sant Pau of Barcelona	Barcelona	Catalonia	Spain	08025
2	Hospital Clínic of Barcelona	Barcelona	Catalonia	Spain	08036
3	Hospital Bellvitge of Barcelona	Barcelona	Catalonia	Spain	08907
4	Fundación Hospital Alcorcón	Alcorcón - Madrid	Madrid	Spain	28922
5	Hospital de Cruces	Bilbao	Vizcaya	Spain	48903
6	Hospital Gregorio Marañón	Madrid		Spain	28007
7	Hospital Ramón y Cajal	Madrid		Spain	28034
8	Hospital La Paz	Madrid		Spain	28046
9	Hospital Virgen Macarena	Sevilla		Spain	410071
10	Hospital Virgen del Rocío	Sevilla		Spain	41013