Efficacy of short duration sequential therapy versus standard intravenous therapy for patients with uncomplicated catheter related bacteremia due to S. aureus methicillin-susceptible.

Conditions: on complicated Catheter related S. aureus meticillin sensible bacteremia
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2013-000511-24-ES

Lead Sponsor: FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

? Patients ? 18 years with a minimum weight of 40 kg.
? Microbiological isolation of S. aureus susceptible to methicillin.
? To start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.
? Prescription of treatment must be prior, independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

? Polymicrobial bacteremia.
? Neutropenic patients.
? Patients addicted to intravenous drugs.
? Patients with malignancies with expected survival less than 6 months.
? Severe allergy to beta-lactams.
? Creatinine clearance <20ml/min.
? Need for hemodialysis, peritoneal dialysis or plasmapheresis.
? Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis.
? Predictors of complicated bacteremia:
Positive blood culture for 48-96 hours of starting treatment antistaphylococcal
Clinical instability
Signs of sepsis or persistent fever on day 4 of treatment
Existence of joint prostheses or valvular or vascular, vascular catheter not removed within three days
Underlying heart disease or endocarditis.
? Patients who present at diagnosis concomitant infection by another organism.
? Not have signed informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the eficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin susceptible, selected based on a set of pre-established criteria equals the pattern of the conventional intravenous;Secondary Objective: Reduce hospital stay associated with the treatment of uncomplicated bacteremia S. aureus.<br><br>Increasing efficiency in the management of patients with bacteremia by S. aureus MS, reducing the number of echocardiographic evaluation.;Primary end point(s): Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin susceptible below 2%.;Timepoint(s) of evaluation of this end point: 14 days of treatment<br> 6 months after extraction of hemoculture

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mortality rate evaluated at 7, 14 and 30 days <br><br>Recovery rate: Evaluated at<br><br>At the end of treatment (14 days)<br>At the end of follow-up period (6 month);Timepoint(s) of evaluation of this end point: Mortality rate evaluated at 7, 14 and 30 days <br><br>Recovery rate: Evaluated at<br><br>At the end of treatment (14 days)<br>At the end of follow-up period (6 month)